UltraFlo Insulin Pen Needle

GUDID B7443357733

31G X 5/16" (8mm)

QUALITY MEDICAL PRODUCTS USA, INC.

Autoinjector needle
Primary Device IDB7443357733
NIH Device Record Keydf06f49d-b6d8-4fd1-8bf0-caf7ea618857
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraFlo Insulin Pen Needle
Version Model Number335773
Company DUNS054180248
Company NameQUALITY MEDICAL PRODUCTS USA, INC.
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB7443357730 [Unit of Use]
HIBCCB7443357731 [Primary]
HIBCCB7443357732 [Package]
Contains: B7443357731
Package: Inner Case [12 Units]
In Commercial Distribution
HIBCCB7443357733 [Package]
Contains: B7443357732
Package: Carton [4 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 Number2
Public Version Date2020-01-20
Device Publish Date2019-06-24

On-Brand Devices [UltraFlo Insulin Pen Needle]

B744335776333G x 5/32" (4mm)
B744335774332G X 5/32" (4mm)
B744335773331G X 5/16" (8mm)
B744335772331G X 3/16" (5mm)
B744335771329G X 1/2" (12mm)

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