FDA.reportPublic FDA data

Diathrive HEALTH Insulin Pen Needle

Primary DI
06975965297229
Brand
Diathrive HEALTH Insulin Pen Needle
Company
Promisemed Hangzhou Meditech Co., Ltd.
Model
IPN-31-6
Device description
The products are sterile with aSterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type hasseveral 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 thesilicone oil is used to needle tube lubrication.The products are for OTC use, andthey are external communication, blood indirect devices. The contact duration for both subjecteddevices is within 24h, and they belong to limited contact device according ISO 10993-1.
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMINeedle, Hypodermic, Single Lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16975965297226PackageGS150In Commercial Distribution
06975965297229PrimaryGS10
86975965297225Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697596529722616975965297226
06975965297229069759652972296975965297229
8697596529722586975965297225

GMDN Terms#

Term, Definition table
TermDefinition
Autoinjector needleA device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.

Regulatory Flags#

DUNS number
421335278
Device count
100
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975965297250Diathrive HEALTH Insulin Pen NeedleIPN-32-62024-08-07
06975965295263TonmiCare Pen NeedlesIPN-32-42024-08-07
06975965297205Diathrive HEALTH Insulin Pen NeedleIPN-29-122024-08-07
06975965297212Diathrive HEALTH Insulin Pen NeedleIPN-31-52024-08-07
06975965297236Diathrive HEALTH Insulin Pen NeedleIPN-31-82024-08-07
06975965297243Diathrive HEALTH Insulin Pen NeedleIPN-32-42024-08-07
06975965297717TonmiCare Pen NeedlesIPN-32-42024-08-07
16975965295260TonmiCare Pen NeedlesIPN-32-42024-08-07
06975965295928TonmiCare Pen NeedlesIPN-31-52024-08-07
86975965297201Diathrive HEALTH Insulin Pen NeedleIPN-29-122024-08-07
86975965297218Diathrive HEALTH Insulin Pen NeedleIPN-31-52024-08-07
16975965297226Diathrive HEALTH Insulin Pen NeedleIPN-31-62024-08-07
16975965297233Diathrive HEALTH Insulin Pen NeedleIPN-31-82024-08-07
16975965297240Diathrive HEALTH Insulin Pen NeedleIPN-32-42024-08-07
16975965297257Diathrive HEALTH Insulin Pen NeedleIPN-32-62024-08-07
16975965297714TonmiCare Pen NeedlesIPN-32-42024-08-07
06971227408679CareTouchIPN-33-42022-07-30
06971227408686CareTouchIPN-32-42022-07-30
06971227408693CareTouchIPN-32-52022-07-30
06971227408709CareTouchIPN-31-82022-07-30

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Primary DI, Brand, Company table
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00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
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