Verifine

GUDID 10850011833794

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.

Insulin syringe/needle, basic

• Primary Device ID: 10850011833794
• NIH Device Record Key: 9e21a029-01e1-40e3-b380-cf1ce7e3c97f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verifine
• Version Model Number: ISY-8103108-100
• 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	00850011833797 [Primary]
GS1	10850011833794 [Package]; Contains: 00850011833797; Package: [20 Units]; In Commercial Distribution
GS1	80850011833793 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223453

FDA Product Code

• FMF: Syringe, Piston

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