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Address: 12640 Branford St., Pacoima, California 91331, USA
www.nu-hope.com |
Send Inquiry |
Phone: +1-(818)-899-7711, 800-899-5017
FDA Registration: 2014640 Year Established: 1959
Annual Revenues: USD 1-5 Million
Employee Count: ~30
Quality: CE Certified
Products: Neonatal Ostomy Pouches, Catheter Strap, Ostomy Support Belt, Catheter Tube Holder Strap, Drainable Pouches, Bulb Irrigation Syringe, ...
Nu-Hope Laboratories, Inc. specializes in ostomy appliances and accessories. Our product categories are belts, pouches, adhesives, neonatal, skin care, skin barriers, specialty products and accessorie
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Address: 15371, Roosevelt Blvd., Suite 100, Clearwater, Florida 33760, USA
www.genairex.com |
Send Inquiry |
Phone: +1-(877)-726-4400
FDA Registration: 1064486
Products: Ostomy Pouches, Drainable Pouches, Ostomy Drainage Bag (FDA Code:
FON), Colostomy Pouch (FDA Code:
EZQ), Disposable Colostomy Appliance (FDA Code:
EZS), Ostomy Collector (FDA Code:
EXB), ...
Genairex, Inc. provides ostomy appliances. Our Securi -T™ is a drainable pouch. It is transparent and has 1-sided comfort panel tape collar. Our hydrocolloid skin barrier strips are skin-friendl
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Address: 3803 East Lake Street, Minneapolis, Minnesota 55406, USA
Phone: +1-(612)-722-4783
Products: Ostomy Collector (FDA Code:
EXB), Ostomy Size Selector (FDA Code:
EXA), ...
Health Care Marketing, Inc. Dba Perry Products deals with ostomy size selectors & collectors.
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Address: Richard Street, Aston, Birmingham B7 4AA, United Kingdom
www.salts.co.uk |
Send Inquiry |
Phone: +44-(121)-333-2000
FDA Registration: 9617198 Annual Revenues: USD 10-25 Million
Employee Count: ~200
Quality: ISO 9000, ISO 9001, ISO 9002, CE Certified
Products: Consulting Services, Management Consulting, Onsite Consulting Service, ASP Consulting Services, Architectural Consulting Services, 3D Imaging Consulting Service, Diagnostic Consulting Services, ...
Salts Healthcare is a manufacturer and supplier of stoma care & orthotic products. Dermacol® is a stoma collar that provides a leak proof barrier around the base of the stoma, preventing output fr
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FDA Code / Regulation: EXA / 876.5900 An ostomy pouch and accessories is a device that consists of a bag that is attached to the patient's skin by an adhesive material and that is intended for use as a receptacle for collection of fecal material or urine following an ileostomy, colostomy, or ureterostomy (a surgically created opening of the small intestine, large intestine, or the ureter on the surface of the body). This generic type of device and its accessories includes the ostomy pouch, ostomy adhesive, the disposable colostomy appliance, ostomy collector, colostomy pouch, urinary ileostomy bag, urine collecting ureterostomy bag, ostomy drainage bag with adhesive, stomal bag, ostomy protector, and the ostomy size selector, but excludes ostomy pouches which incorporate arsenic-containing compounds.
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 876.9.