Unifine Pentips - 5mm x 31G AN3450

GUDID 00384703450011

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384703450011
NIH Device Record Key5a92f4f8-8459-4f2a-a21a-ceaa76eb481a
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips - 5mm x 31G
Version Model NumberAN3450
Catalog NumberAN3450
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
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com
Phone770-977-2226
Emailinfo@owenmumfordinc.com

Device Dimensions

Length5 Millimeter
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter
Needle Gauge31 Gauge
Length5 Millimeter

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703450001 [Unit of Use]
GS100384703450004 [Unit of Use]
GS100384703450011 [Primary]
GS100384703450028 [Package]
Package: Sleeve [10 Units]
In Commercial Distribution
GS100384703450035 [Package]
Contains: 00384703450028
Package: Case [50 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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

On-Brand Devices [Unifine Pentips - 5mm x 31G]

00384703550018For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384703450011For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702050014For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384701150012For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550912For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550813For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550714For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550615For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550516For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550417For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550318For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550219For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700550011For use with injectors for the subcutaneous injection of approved drugs, including insulin

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