SEARCH RESULTS FOR: 葵湧OTC网：(www.hkotc.cc)4t7x(8333 results)
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033108-100
In Commercial Distribution
- 10850011833756 ()
- 00850011833759 ()
- 80850011833755 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution
- 10850011833565 ()
- 00850011833568 ()
- 80850011833564 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution
- 10850011833558 ()
- 00850011833551 ()
- 80850011833557 ()
- Insulin syringe/needle, basic
Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.
Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns.
SYNEDGEN, INC.
3 oz
In Commercial Distribution
- 00852181005332 ()
- Total Volume: 3 Fluid Ounce
- Wound hydrogel dressing, non-antimicrobial
Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control.
ARKRAY USA, INC.
502030
In Commercial Distribution
- 00015482502300 ()
- 50015482502305 ()
- 10015482502307 ()
N/A
- Glucose monitoring system IVD, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
4c
In Commercial Distribution
- 00852305002070 ()
- Denture reliner, soft, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
2ps
In Commercial Distribution
- 00852305002018 ()
- Denture reliner, soft, home-use
Refill For SmartCompliance Cabinet With OTC Medications - Contains: Alcohol Pad, 20 ct; Antibiotic Ointment, 10 ct; Antiseptic Wipes, 10 ct; Aspirin Tablets, 20 ct; Butterfly Wound Closure, 10 ct; Extra-Strength Non-Aspirin Tablets, 20 ct; Fabric Bandage, 1" x 3", 50 ct; Fingertip Fabric Bandage, 10 ct; First Aid Tape, 1/2" x 10 yd; First Aid/Burn Cream, 10 ct; Gauze Roll Bandage, 3”; Ibuprofen Tablets, 40 ct; Knuckle Fabric Bandage, 10 ct; Plastic Bandage, 3/4" x 3", 25 ct.
Acme United Corporation
700002
In Commercial Distribution
- 00092265700023 ()
700002
- First aid kit, medicated
ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
MediVena, LLC
AC500
In Commercial Distribution
- 00810008210512 ()
- 00810008210369 ()
- 00810008210529 ()
4007
- Glucose monitoring system IVD, home-use
A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.
MIEUX LLC
1
Not in Commercial Distribution
- 00868609000216 ()
- Menstrual cup, non-latex, reusable