Carefine

GUDID 01850011833116

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: 01850011833116
• NIH Device Record Key: 53b6172c-fba9-4e99-ace3-86062c51abdd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Carefine
• Version Model Number: IPN-33-04
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011833117 [Primary]
GS1	01850011833116 [Package]; Contains: 00850011833117; Package: [100 Units]; In Commercial Distribution
GS1	08850011833119 [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: 2025-11-28
• Device Publish Date: 2025-11-20

On-Brand Devices [Carefine]

• 01850011833116: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 01850011833109: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 01850011833093: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 01850011833086: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 01850011833079: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 01850011833062: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L
• 01850011833055: The proposed product, insulin pen needle, is manufactured by Promisemed Hangzhou Meditech Co., L