CDC- Premier Value- 33G x 4mm pen needles w/remover AN 3860CDC

GUDID 00761059311003

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

PHARMACY VALUE ALLIANCE, LLC

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle
Primary Device ID00761059311003
NIH Device Record Key851d9ea6-625d-4165-ba2d-ac87fa659792
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDC- Premier Value- 33G x 4mm pen needles w/remover
Version Model NumberAN 3860CDC
Catalog NumberAN 3860CDC
Company DUNS089138159
Company NamePHARMACY VALUE ALLIANCE, LLC
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com
Phone435-649-7251
EmailUSCustomerService@owenmumford.com

Device Dimensions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703860001 [Unit of Use]
GS100761059311003 [Package]
Contains: 00840986036781
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059312000 [Package]
Package: Case [4 Units]
In Commercial Distribution
GS100840986036781 [Primary]

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 Date2021-06-02
Device Publish Date2021-05-25

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00761059311003 - CDC- Premier Value- 33G x 4mm pen needles w/remover2021-06-02For use with injectors for the subcutaneous injection of approved drugs, including insulin
00761059311003 - CDC- Premier Value- 33G x 4mm pen needles w/remover2021-06-02 For use with injectors for the subcutaneous injection of approved drugs, including insulin
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