Verifine

GUDID 10850011833206

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.

Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use Blood lancet, single-use

• Primary Device ID: 10850011833206
• NIH Device Record Key: de140947-5cf9-436c-97e9-33af88734269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Verifine
• Version Model Number: SL-2118M
• 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	00850011833209 [Primary]
GS1	10850011833206 [Package]; Contains: 00850011833209; Package: carton [20 Units]; In Commercial Distribution
GS1	80850011833205 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221368

FDA Product Code

• FMK: Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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