Diathrive HEALTH Insulin Pen Needle

GUDID 16975965297257

The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.

Promisemed Hangzhou Meditech Co., Ltd.

Autoinjector needle

• Primary Device ID: 16975965297257
• NIH Device Record Key: e16ed2cf-fd41-48fa-a6dc-5b42a7c88028
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diathrive HEALTH Insulin Pen Needle
• Version Model Number: IPN-32-6
• Company DUNS: 421335278
• Company Name: Promisemed Hangzhou Meditech Co., Ltd.
• 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: true
• 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	06975965297250 [Primary]
GS1	16975965297257 [Package]; Contains: 06975965297250; Package: carton [50 Units]; In Commercial Distribution
GS1	86975965297256 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210059

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: 2024-08-15
• Device Publish Date: 2024-08-07

On-Brand Devices [Diathrive HEALTH Insulin Pen Needle]

• 16975965297257: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 16975965297240: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 16975965297233: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 16975965297226: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 86975965297218: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl
• 86975965297201: The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl