Diathrive HEALTH Insulin Pen Needle

GUDID 16975965297226

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 ID16975965297226
NIH Device Record Keybe86c36d-bb4e-4eea-92cb-1e33b0cdc0e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiathrive HEALTH Insulin Pen Needle
Version Model NumberIPN-31-6
Company DUNS421335278
Company NamePromisemed Hangzhou Meditech Co., Ltd.
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975965297229 [Primary]
GS116975965297226 [Package]
Contains: 06975965297229
Package: carton [50 Units]
In Commercial Distribution
GS186975965297225 [Unit of Use]

FDA Product Code

FMINeedle, Hypodermic, Single Lumen

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-15
Device Publish Date2024-08-07

On-Brand Devices [Diathrive HEALTH Insulin Pen Needle]

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

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