CDC - Premier Value - 32Gx4mm pen needles w/remover AN 3840CDC

GUDID 00840986029646

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

PHARMACY VALUE ALLIANCE, LLC

Autoinjector needle
Primary Device ID00840986029646
NIH Device Record Key9412b978-885d-472a-8728-90d98defd030
Commercial Distribution StatusIn Commercial Distribution
Brand NameCDC - Premier Value - 32Gx4mm pen needles w/remover
Version Model NumberAN 3840CDC
Catalog NumberAN 3840CDC
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Customer Support Contacts

Phone435-649-7251
Emailxx@xx.xx

Device Dimensions

Needle Gauge32 Gauge

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100384703840000 [Unit of Use]
GS100761059841289 [Package]
Package: Sleeve [6 Units]
In Commercial Distribution
GS100761059842286 [Package]
Contains: 00761059841289
Package: Case [24 Units]
In Commercial Distribution
GS100840986029646 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-19

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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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