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Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare
provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-28G
In Commercial Distribution
- 80850011833601 ()
- 00850011833605 ()
- 10850011833602 ()
- Blood lancet, single-use
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
Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle.
The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Promisemed Medical Devices Inc.
SL-3018T
In Commercial Distribution
- 10850011833534 ()
- 00850011833537 ()
- 80850011833533 ()
- Blood lancet, single-use
Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare
provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-30G
In Commercial Distribution
- 10850011833503 ()
- 00850011833506 ()
- 80850011833502 ()
- Blood lancet, single-use
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-04
In Commercial Distribution
- 10850011833497 ()
- 00850011833490 ()
- 80850011833496 ()
- Autoinjector needle
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-29-12
In Commercial Distribution
- 10850011833480 ()
- 00850011833483 ()
- 80850011833489 ()
- Autoinjector needle
Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument intended to be used by a healthcare
provider or patient self to manually puncture the skin to obtain a small blood specimen.
Promisemed Medical Devices Inc.
BL-33G
In Commercial Distribution
- 10850011833442 ()
- 00850011833445 ()
- 80850011833441 ()
- Blood lancet, single-use
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-08
In Commercial Distribution
- 10850011833435 ()
- 00850011833438 ()
- 80850011833434 ()
- Autoinjector needle
The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. Different models are distinguished by needle gauge and length.
Promisemed Medical Devices Inc.
IPN-31-05
In Commercial Distribution
- 10850011833428 ()
- 00850011833421 ()
- 80850011833427 ()
- Autoinjector needle