FDA.reportPublic FDA data

Diathrive HEALTH Insulin Pen Needle

Primary DI
16975965297226
Brand
Diathrive HEALTH Insulin Pen Needle
Company
Promisemed Hangzhou Meditech Co., Ltd.
Model
IPN-31-6
Device description
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.
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
421335278
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06975965297229Diathrive HEALTH Insulin Pen NeedleIPN-31-62024-08-07
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840464800026Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800033Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800040Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800057Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
00840464800064Intraosseous Infusion NeedlesEcs Opco 1 LLCFMI2026-05-27
10840330704868ProCureTwin Med, LLCFMI2026-05-27
10840330704875ProCureTwin Med, LLCFMI2026-05-27
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08586015044830CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.FMI2026-04-27
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08800052609280Sure Fine Pen Needle 31G 5mmSHINA MED CORPORATIONFMI2026-03-25
08800052609297"Sure Fine Pen Needle 29G x 1/2"""SHINA MED CORPORATIONFMI2026-03-25
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