Profile: Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing products, oxygen regulator and diabetic care products. We provide gloves in small, large and extra large sizes for medical use. Our diabetic care products include glucose monitor kits and glucose test strips. We also provide surgical instruments such as bone plasters, diagnostics, ear instruments, forceps, needles & probes, scissors, sponge and needle holders.

FDA Registration Number: 1062671

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• Abdominal Binders (FDA Code: FSD / 880.5160)

• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

• Adult Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues.

• Aneroid Sphygmomanometer

• Anesthesiology Oropharyngeal Airway (FDA Code: CAE / 868.5110) An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

• Anesthetic Gas Mask (FDA Code: BSJ / 868.5550) An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway.

• Arm Slings (FDA Code: ILI / 890.3640) An arm sling is a device intended for medical purposes to immobilize the arm, by means of a fabric band suspended from around the neck.

• Back-Pressure Compensated Flowmeter (FDA Code: CAX / 868.2340) A compensated thorpe tube flowmeter is a device intended for medical purposes that is used to control and measure gas flow rate accurately. The device includes a vertically mounted tube, with the outlet of the flowmeter calibrated to a reference pressure.

• Balloon Retention Type Catheter (FDA Code: EZL / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Battery-Powered Medical Examination Light (FDA Code: KYT / 880.6350) A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• Bedpan (FDA Code: FOB / 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.

• Blood Collection Lancet (FDA Code: FMK / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Blood Glucose Monitor Kit

• Blood Glucose Test Strips

• Blood pressure Cuffs (FDA Code: DXQ / 870.1120) A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

• Body Bag, Cadaver

• Bourdon Gauge Non-Back-Pressure Compensated Gas Flowmeter (FDA Code: CCN / 868.2300) A bourdon gauge flowmeter is a device intended for medical purposes that is used in conjunction with respiratory equipment to sense gas pressure. The device is calibrated to indicate gas flow rate when the outflow is open to the atmosphere.

• Burn Sheet (FDA Code: FPY / 880.5180) A burn sheet is a device made of a porous material that is wrapped aroung a burn victim to retain body heat, to absorb wound exudate, and to serve as a barrier against contaminants.

• Cardiology Stethoscope

• Cardiopulmonary Board (FDA Code: FOA / 880.6080) A cardiopulmonary resuscitation board is a device consisting of a rigid board which is placed under a patient to act as a support during cardiopulmonary resuscitation.

• Cast Component (FDA Code: LGF / 888.5940) A cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron.

• Catheter Accessories (FDA Code: KGZ / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Catheter Needle (FDA Code: GCB / 878.4200)

• Cervical Collar Bags

• Clinical Mercury Thermometers (FDA Code: FLK / 880.2920) A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

• Cold & Hot Packs

• Cold Pack

• Compression Dressing (FDA Code: MHW / 880.5075) An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.

• Continuous Electronic Thermometer (FDA Code: FLL / 880.2910) A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

• Digital Thermometers

• Disposable Hot/Cold Pack (FDA Code: IMD / 890.5710) A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.

• Disposable Medical Bed (FDA Code: KME / 880.6060) Medical disposable bedding is a device intended for medical purposes to be used by one patient for a period of time and then discarded. This generic type of device may include disposable bedsheets, bedpads, pillows and pillowcases, blankets, emergency rescue blankets, or waterproof sheets.

• Disposable Medical Scissors (FDA Code: JOK / 880.6820) Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.

• Disposable Penlights

• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)

• Disposable Vaginal Speculum

• Elastic Bandages (FDA Code: FQM / 880.5075)

• Electrocardiograph Electrode (FDA Code: DRX / 870.2360) An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

• Emesis Basin (FDA Code: FNY / 880.6730)

• Esophageal Stethoscopes (FDA Code: BZW / 868.1910) An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

• Extension Airway Connector (FDA Code: BZA / 868.5810) An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

• External Inflatable Extremity Splint (FDA Code: FZF / 878.3900) An inflatable extremity splint is a device intended to be inflated to immobilize a limb or an extremity.

• External Non-Inflatable Extremity Splint (FDA Code: FYH / 878.3910) A noninflatable extremity splint is a device intended to immobilize a limb or an extremity. It is not inflatable.

• Finger Splints

• Fluorescence Wood's Light Test (FDA Code: GMB / 866.2600) A Wood's fluorescent lamp is a device intended for medical purposes to detect fluorescent materials (e.g., fluorescein pigment produced by certain microorganisms) as an aid in the identification of these microorganisms. The device aids in the diagnosis of disease.

• Foley Catheter Holders (FDA Code: EYJ / 876.5130)

• Forceps (FDA Code: HTD / 878.4800)

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Glove Box Holders