Premier Value 1st Tier Unifine Pentips Plus - 4mm x 33G Sample Bags

GUDID 00384703860001

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

OWEN MUMFORD USA INCORPORATED

Autoinjector needle
Primary Device ID00384703860001
NIH Device Record Key7f98dff9-714c-4da7-a584-0f1371ba7265
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremier Value 1st Tier Unifine Pentips Plus - 4mm x 33G Sample Bags
Version Model NumberAN 0860CDCSB2
Company DUNS803401454
Company NameOWEN MUMFORD USA INCORPORATED
Device Count2
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 Latexfalse
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

Device Dimensions

Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 Gauge
Length4 Millimeter
Needle Gauge33 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
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
GS100093351029929 [Primary]
GS100384703860001 [Unit of Use]
GS100761059860280 [Primary]
GS100761059862284 [Package]
Contains: 00761059860280
Package: Case [200 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 Date2021-02-08
Device Publish Date2021-01-29

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