Unifine Pentips Plus - 4mm x 32G AN2840

GUDID 00384702840028

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384702840028
NIH Device Record Key65c19783-9ccf-432a-b7d6-f584505e9b3a
Commercial Distribution StatusIn Commercial Distribution
Brand NameUnifine Pentips Plus - 4mm x 32G
Version Model NumberAN2840
Catalog NumberAN2840
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count90
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

Length4 Millimeter
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

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
GS100384702840001 [Unit of Use]
GS100384702840011 [Primary]
GS100384702840028 [Package]
Contains: 00384702840011
Package: Sleeve [6 Units]
In Commercial Distribution
GS100384702840035 [Package]
Package: Case [24 Units]
In Commercial Distribution
GS100384703840003 [Unit of Use]

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 Plus - 4mm x 32G]

00384703840010For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384702840028For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840914For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840815For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840716For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840617For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840532For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840419For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840310For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840211For use with injectors for the subcutaneous injection of approved drugs, including insulin
00384700840013For use with injectors for the subcutaneous injection of approved drugs, including insulin

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