Verifine

GUDID 10850011833046

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.

Autoinjector needle

• Primary Device ID: 10850011833046
• NIH Device Record Key: 6ef05a1c-16a2-4d6d-ad0b-b0a962e77c75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verifine
• Version Model Number: IPN-32-04
• Company DUNS: 114566189
• Company Name: Promisemed Medical Devices Inc.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011833049 [Primary]
GS1	10850011833046 [Package]; Contains: 00850011833049; Package: [50 Units]; In Commercial Distribution
GS1	80850011833045 [Unit of Use]

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-28
• Device Publish Date: 2023-08-18

On-Brand Devices [Verifine]

• 10850011833824: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833794: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833787: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833770: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833763: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833756: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833732: Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument in
• 10850011833695: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 80850011833687: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833671: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 80850011833601: Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument in
• 10850011833565: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833558: The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plu
• 10850011833534: Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood samplin
• 10850011833503: Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument in
• 10850011833497: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833480: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833442: Blood Lancet is a sterile, handheld, sharply-pointed, non-mechanical, scalpel-like instrument in
• 10850011833435: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833428: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833275: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833268: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833251: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833244: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 10850011833237: Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood samplin
• 10850011833206: Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood samplin
• 10850011833138: Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood samplin
• 10850011833046: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 00850011833940: The Sharps container is single-use, disposable, non-sterile containers intended to be used for h