SEARCH RESULTS FOR: 葵湧OTC网：(www.hkotc.cc)4t7x(7863 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-8052912-100
In Commercial Distribution
- 10850011833763 ()
- 00850011833766 ()
- 80850011833762 ()
- 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-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
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
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has
several models. Different models are distinguished by needle gauge and length.
The Blood Lancet consists of needle tube and needle hub.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
11G-2091-K
In Commercial Distribution
- 86971227402543 ()
- 06971227402547 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has
several models. Different models are distinguished by needle gauge and length.
The Blood Lancet consists of needle tube and needle hub.
The products are for OTC use, and
they are external communication, blood indirect devices. The contact duration for both subjected
devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
11G-2090-J
In Commercial Distribution
- 06971227402530 ()
- 86971227402536 ()
- Autoinjector needle
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