Emesis Basin Suppliers
Limit companies to: Worldwide USA
Liv Medica Equipments Private Limited | Address: B-26, Phase Ii, Mepz, Thambaram, Chennai, Tamil Nadu 600 045, India 
www.livmedica.in | Send Inquiry | Phone: +91-(44)-22621231
Products: Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Compression Dressing (FDA Code: MHW), ...
Liv Medica Equipments Pvt. Ltd supplies first aid kits, components and medical disposals. Our products include non-rebreathing oxygen masks, non-sterile specimen containers, elastic bandages, non-ster more...
www.livmedica.in | Send Inquiry | Phone: +91-(44)-22621231
Products: Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Compression Dressing (FDA Code: MHW), ...
Liv Medica Equipments Pvt. Ltd supplies first aid kits, components and medical disposals. Our products include non-rebreathing oxygen masks, non-sterile specimen containers, elastic bandages, non-ster more...
Lm First Aid Products Pvt Ltd | Address: 3/395 Mookambiga Nagar, Kattupakkam, Chennai, Tamil Nadu 600045, India
Phone: +91-(727)-4492150
Products: Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Compression Dressing (FDA Code: MHW), ...
Lm First Aid Products Pvt Ltd offers first aid kits, medical disposables, medical dressings, emergency preparedness/first responder kits, gauze dressings and gloves-latex vinyl & nitrile. We provide a more...
Phone: +91-(727)-4492150
Products: Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), Compression Dressing (FDA Code: MHW), ...
Lm First Aid Products Pvt Ltd offers first aid kits, medical disposables, medical dressings, emergency preparedness/first responder kits, gauze dressings and gloves-latex vinyl & nitrile. We provide a more...
General Surgical Co., (india) Pvt. Ltd. | Address: G-6 Gee Cee Crescent, 114, Ponamallee High Road, Chennai, Tamil Nadu 60084, India
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
www.gescoindia.com | Send Inquiry | Phone: +91-(44)-2825 96 02
FDA Registration: 9613926 Quality: ISO 9001:2000 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Surgical Marking Pens (FDA Code: HRP), Gastroenterologic Needle Holder (FDA Code: FHQ), ...
General Surgical Co., (india) Pvt. Ltd. is a manufacturer of surgical instruments. We produce medical & surgical disposables, general, ENT, neuro & spinal, orthopedic, gynecology & obstetrics, plastic more...
Zepf Medical Instruments GmbH | Address: 21 Gunninger St., Seitingen-Oberflacht D-78606, Germany 
www.zepf-medical-instruments.de | Send Inquiry | Phone: +49-(7464)-98506-0
FDA Registration: 3003244954
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), Pneumatic Tourniquet (FDA Code: KCY), ...
Zepf Medical Instruments GmbH is a manufacturer of medical instruments and related products. We keep in stock a full range of surgical instruments and related items. more...
www.zepf-medical-instruments.de | Send Inquiry | Phone: +49-(7464)-98506-0
FDA Registration: 3003244954
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Wire Twisters (FDA Code: HXS), Pneumatic Tourniquet (FDA Code: KCY), ...
Zepf Medical Instruments GmbH is a manufacturer of medical instruments and related products. We keep in stock a full range of surgical instruments and related items. more...
Vehu Medical Gmbh | Address: 48 Semmelweisstraße, Tuttlingen 78532, Germany
www.vehu.com | Send Inquiry | Phone: +49-(7461)-163311
FDA Registration: 9616246
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, ...
Vehu Medical Gmbh provides surgical accessory applicator, cotton, forceps, extractor, scissors, ophthalmic fork, syringe, retractor, stethoscopes, head mirrors, needles, dissector, surgical clip, oper more...
www.vehu.com | Send Inquiry | Phone: +49-(7461)-163311
FDA Registration: 9616246
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, ...
Vehu Medical Gmbh provides surgical accessory applicator, cotton, forceps, extractor, scissors, ophthalmic fork, syringe, retractor, stethoscopes, head mirrors, needles, dissector, surgical clip, oper more...
Dimeda Instrumente Gmbh | Address: Gansacker 54+58, Tuttlingen 78532, Germany
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
www.dimeda.de | Send Inquiry | Phone: +49-(7462)-94-61-0
FDA Registration: 9611283 Year Established: 1976
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Uterine Sound Instruments, Lacrimal Dilators and Cannulas, Gastroenterologic Needle Holder (FDA Code: FHQ), ...
Dimeda Instrumente Gmbh specializes in surgical instruments. We offer products for endoscopy, neurosurgery, cardiovascular surgery, gynecology, orthopedics and plastic surgery. Our product list compri more...
Elcon Medical Instruments GmbH | Address: Dr. Karl-Storz-Straße 26, Tuttlingen D-78532, Germany
www.elcon-medical.com | Send Inquiry | Phone: +49-(7461)-9281-0
FDA Registration: 8043816 Quality: ISO 13485:2003 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), Mouth Gags (FDA Code: KBN), ...
Elcon Medical Instruments GmbH is a manufacturer and distributor of surgical instruments. Our wide range of instruments cover all surgical disciplines. We offer instruments for general surgery, gyneco more...
www.elcon-medical.com | Send Inquiry | Phone: +49-(7461)-9281-0
FDA Registration: 8043816 Quality: ISO 13485:2003 Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), Mouth Gags (FDA Code: KBN), ...
Elcon Medical Instruments GmbH is a manufacturer and distributor of surgical instruments. Our wide range of instruments cover all surgical disciplines. We offer instruments for general surgery, gyneco more...
Gimmi GmbH | Address: Carl-Zeiss-Strasse 6, Tuttlingen, Baden-Wuerttemberg D-78532, Germany
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Yasargil Aneurysm Clips, Self-Retaining Retractors (FDA Code: FFO), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
www.gimmi.de | Send Inquiry | Phone: +49-(7461)-96 590-0
FDA Registration: 3010607620 Annual Revenues: < USD 1 Million Employee Count: ~20 Quality: ISO 9001, CE Certified
Products: Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Yasargil Aneurysm Clips, Self-Retaining Retractors (FDA Code: FFO), Biopsy Forceps Femoral Approach, Biopsy Forceps, Internal Jugular Approach, ...
Gimmi GmbH manufactures and distributes medical products. We specialize in instruments & equipment for endoscopy. Our product line ranges from instruments for general surgery to our developed endoscop more...
CM Instrumente GmbH | Address: Im Gänsäcker 56, Tuttlingen, Deutschland 78532, Germany
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
www.cm-instrumente.de | Send Inquiry | Phone: +49-(7462)-2042070
FDA Registration: 9680518
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), ...
Cm Instrumente Gmbh is a manufacturer and distributor of surgical instruments & surgical implants. Our surgical instruments include osteosynthesis, aluminum rib spreaders, atraumatic cardiovascular cl more...
Agencinox S.A. | Address: Zone Industrielle, Aillant Sur Tholon 89110, France
www.agencinox.com | Phone: +33-(3)-86-92-39-27
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Ophthalmology, Surgical Instrument Tables, Ophthalmology, Surgical Instrument Trays, Urinals (FDA Code: FNP), Surgical Tables Accessories, Infusion Stand, Surgical Instrument Table, Infusion Stand (FDA Code: FOX), ...
Agencinox S.A. specializes in the production, distribution and export of medical equipment & furniture. Our products include auto-sink for bedpans & urinals, draining & filling stations, exam tables, more...
www.agencinox.com | Phone: +33-(3)-86-92-39-27
Annual Revenues: USD 5-10 Million Employee Count: ~50 Quality: ISO 9001 Certified
Products: Ophthalmology, Surgical Instrument Tables, Ophthalmology, Surgical Instrument Trays, Urinals (FDA Code: FNP), Surgical Tables Accessories, Infusion Stand, Surgical Instrument Table, Infusion Stand (FDA Code: FOX), ...
Agencinox S.A. specializes in the production, distribution and export of medical equipment & furniture. Our products include auto-sink for bedpans & urinals, draining & filling stations, exam tables, more...
Technimed | Address: 16 Rue Michelet, St Leu La Foret 95320, France
Phone: +33-(1)-30-40-84-70
FDA Registration: 3005089758
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Technimed provides pharmaceutical products. more...
Phone: +33-(1)-30-40-84-70
FDA Registration: 3005089758
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Human Bone Rasps (FDA Code: HTR), Medical Rasps (FDA Code: HTR), ...
Technimed provides pharmaceutical products. more...
Electro Medical Apparatus | Address: 41 El Saki Street, El Sabteya, Cairo, Egypt
www.electromedicalapparatus.com | Phone: +20-(2)-2576-3196
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Infusion Stand (FDA Code: FOX), Operating-Room Table and Attachments (FDA Code: BWN), Operating-Room Electrical Table (FDA Code: GDC), Mechanical Operating Room Table (FDA Code: FWX), Bedpan (FDA Code: FOB), ...
Electro Medical Apparatus offers adjustable hospital AC-powered beds, adjustable hospital hydraulic beds and bedpans. more...
www.electromedicalapparatus.com | Phone: +20-(2)-2576-3196
Products: Adjustable Hospital AC-Powered Beds (FDA Code: FNL), Infusion Stand (FDA Code: FOX), Operating-Room Table and Attachments (FDA Code: BWN), Operating-Room Electrical Table (FDA Code: GDC), Mechanical Operating Room Table (FDA Code: FWX), Bedpan (FDA Code: FOB), ...
Electro Medical Apparatus offers adjustable hospital AC-powered beds, adjustable hospital hydraulic beds and bedpans. more...
Shanghai Hua Yue Packaging Products Co., Ltd. | Address: No.228, Zhai Xing Rd., Xinsi, Zhelin Town, Feng Xian District, Shanghai 201416, China 
Phone: +86-(21)-50301896
FDA Registration: 3004496839
Products: Intestine Bag (FDA Code: KGY), Sterile Specimen Container (FDA Code: FMH), Emesis Basin (FDA Code: FNY), Manual Patient Transfer Device (FDA Code: FMR), Sterile Specimen Mailer and Storage Container (FDA Code: KDT), Sterile Temperature Control Specimen Mailer and Storage Container (FDA Code: KDW), ...
Shanghai Hua Yue Packaging Products Co., Ltd. is a manufacturer of intestine bag, emesis basin, non-sterile specimen container, manual patient transfer device and patient personal hygiene kit. more...
Phone: +86-(21)-50301896
FDA Registration: 3004496839
Products: Intestine Bag (FDA Code: KGY), Sterile Specimen Container (FDA Code: FMH), Emesis Basin (FDA Code: FNY), Manual Patient Transfer Device (FDA Code: FMR), Sterile Specimen Mailer and Storage Container (FDA Code: KDT), Sterile Temperature Control Specimen Mailer and Storage Container (FDA Code: KDW), ...
Shanghai Hua Yue Packaging Products Co., Ltd. is a manufacturer of intestine bag, emesis basin, non-sterile specimen container, manual patient transfer device and patient personal hygiene kit. more...
GRI Medical & Electronic Technology Co., Ltd. | Address: 1805 Honggao Road, Xiuzhou Industry Zone, Jiaxing 314031, China
Phone: +86-(135)-11359722
FDA Registration: 3004911384
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), Surgical Gowns (FDA Code: FYA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
GRI Medical & Electronic Technology Co., Ltd. offers surgical & medical equipments like disposable medical beds, blood collection lancet, surgical trays, ophthalmic patient drape and external brace kn more...
Phone: +86-(135)-11359722
FDA Registration: 3004911384
Products: Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Patient Examination Gowns and Capes (FDA Code: FME), Surgical Trays (FDA Code: LRP), Surgical Gowns (FDA Code: FYA), Adjustable Hospital AC-Powered Beds (FDA Code: FNL), ...
GRI Medical & Electronic Technology Co., Ltd. offers surgical & medical equipments like disposable medical beds, blood collection lancet, surgical trays, ophthalmic patient drape and external brace kn more...
Zhejiang Beiqier Medical Products Co.,Ltd | Address: Bai Long Qiao- Dongxi Industrial Area, Jinhua City 321025, China
www.beiqier.com | Send Inquiry | Phone: +86-(678)-9088180
FDA Registration: 3006798144
Products: Adhesive Plastic, Fracture Bedpans, Male Urinals, Infection Control Systems, Urinals (FDA Code: FNP), Pediatric Urine Collector (FDA Code: KNX), ...
Zhejiang Beiqier Medical Products Co., Ltd specializes in the production medical plastic products. We offer bedpans fracture, rectangular wash basin, bedpan, goggle infection control dispenser, urinal more...
www.beiqier.com | Send Inquiry | Phone: +86-(678)-9088180
FDA Registration: 3006798144
Products: Adhesive Plastic, Fracture Bedpans, Male Urinals, Infection Control Systems, Urinals (FDA Code: FNP), Pediatric Urine Collector (FDA Code: KNX), ...
Zhejiang Beiqier Medical Products Co., Ltd specializes in the production medical plastic products. We offer bedpans fracture, rectangular wash basin, bedpan, goggle infection control dispenser, urinal more...
Nanjing Winice Trade Co., Ltd. | Address: 7FL.D,CFC Building A,No.300 Zhongshan East Road, Nanjing 210002, China
www.njwinice.com | Send Inquiry | Phone: +86-(25)-84490336, 84490338
Quality: ISO13485, CE ceitification Certified
Products: Oxygen Masks (FDA Code: BYG), Face Masks, Endotracheal Tubes, Stomach Tubes, Suction Catheter, Elastic Bandages (FDA Code: FQM), ...
Nanjing Winice Trade Co., Ltd. is a medical products trading company. We provide products and services to the healthcare field, including hospitals, extended care facilities, surgery centers, commerci more...
www.njwinice.com | Send Inquiry | Phone: +86-(25)-84490336, 84490338
Quality: ISO13485, CE ceitification Certified
Products: Oxygen Masks (FDA Code: BYG), Face Masks, Endotracheal Tubes, Stomach Tubes, Suction Catheter, Elastic Bandages (FDA Code: FQM), ...
Nanjing Winice Trade Co., Ltd. is a medical products trading company. We provide products and services to the healthcare field, including hospitals, extended care facilities, surgery centers, commerci more...
Shanghai Amsino Medical Devices Co., Ltd. | Address: 668-5 Hua Jiang Rd., Shanghai 201803, China
Phone: +86-(215)-9117385
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Straight Catheter (FDA Code: EZD), ...
Shanghai Amsino Medical Devices Co., Ltd. is a manufacturer of adult tongue depressors, catheter accessories, non-surgical isolation gowns, oxygen masks, surgical trays, urine leg bags, surgical razor more...
Phone: +86-(215)-9117385
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Straight Catheter (FDA Code: EZD), ...
Shanghai Amsino Medical Devices Co., Ltd. is a manufacturer of adult tongue depressors, catheter accessories, non-surgical isolation gowns, oxygen masks, surgical trays, urine leg bags, surgical razor more...
Shanghai Xinhang Printing Co., Ltd. | Address: 618 Nanda Road, Shanghai 200436, China
Products: Emesis Basin (FDA Code: FNY), ...
Shanghai Xinhang Printing Co., Ltd. is involved in the business of emesis basin. more...
Products: Emesis Basin (FDA Code: FNY), ...
Shanghai Xinhang Printing Co., Ltd. is involved in the business of emesis basin. more...
Suzhou Jinsheng Plastic Co., Ltd. | Address: Xinshi Rd.,Xinjia Industrial, Estate, West Shihu Road, Suzhou, Jiangsu 215028, China
www.js-sj.com | Send Inquiry | Phone: +86-(512)-6561-6868
FDA Registration: 3005245797 Quality: ISO 9001:2000 Certified
Products: Urine Collection Leg Bags (FDA Code: FAQ), Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), Urine Leg Bags (FDA Code: FAQ), Bone Clamp (FDA Code: HXD), Ophthalmic Instrument Stand (FDA Code: HMG), Pediatric Urine Collector (FDA Code: KNX), ...
Suzhou Jinsheng Plastic Co., Ltd. deals with medical disposable materials and health care products. Our product line comprises of piston syringe, first aid kit, hemostatic forceps, triangular graduate more...
www.js-sj.com | Send Inquiry | Phone: +86-(512)-6561-6868
FDA Registration: 3005245797 Quality: ISO 9001:2000 Certified
Products: Urine Collection Leg Bags (FDA Code: FAQ), Sterile Leg Urine Collection Bag for External Use (FDA Code: FAQ), Urine Leg Bags (FDA Code: FAQ), Bone Clamp (FDA Code: HXD), Ophthalmic Instrument Stand (FDA Code: HMG), Pediatric Urine Collector (FDA Code: KNX), ...
Suzhou Jinsheng Plastic Co., Ltd. deals with medical disposable materials and health care products. Our product line comprises of piston syringe, first aid kit, hemostatic forceps, triangular graduate more...
Wenzhou K.L.F. Medical Plastics Co., Ltd. | Address: 258 Yongqiang West Road, Wenzhou, Zhejiang 325024, China
Phone: +86-(577)-863-77483
FDA Registration: 3004538333 Quality: ISO 9002 Certified
Products: AV Fistulas, Extension Tubes, A-v Fistula Clamp, Infusion Sets, Burette, Ear Curette (FDA Code: JYG), ...
Wenzhou K.L.F. Medical Plastics Co., Ltd. focuses on infusion sets, blood transfusion sets and pediatric burette infusion sets. Our products include high burette sets, precise IV sets, AV fistula, ext more...
Phone: +86-(577)-863-77483
FDA Registration: 3004538333 Quality: ISO 9002 Certified
Products: AV Fistulas, Extension Tubes, A-v Fistula Clamp, Infusion Sets, Burette, Ear Curette (FDA Code: JYG), ...
Wenzhou K.L.F. Medical Plastics Co., Ltd. focuses on infusion sets, blood transfusion sets and pediatric burette infusion sets. Our products include high burette sets, precise IV sets, AV fistula, ext more...
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FDA Code / Regulation: FNY / 880.6730
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
