Diabetic Outlet 1st Tier - Unifine Pentips Plus 4mm x 32G

GUDID 00761059841845

For use with injectors for the subcutaneous injection of approved drugs, including insulin.

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00761059841845
NIH Device Record Keya8f438dd-deb6-4bce-84fa-1e9b42809a32
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiabetic Outlet 1st Tier - Unifine Pentips Plus 4mm x 32G
Version Model NumberAN 3840DO
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com
Phone770-977-2226
EmailUSCustomerService@owenmumford.com

Device Dimensions

Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge
Length4 Millimeter
Needle Gauge32 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703840003 [Unit of Use]
GS100761059840848 [Primary]
GS100761059841845 [Package]
Contains: 00761059840848
Package: Sleeve [10 Units]
In Commercial Distribution
GS100761059842842 [Package]
Package: Case [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-06-04
Device Publish Date2021-05-27

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