TRUEplus - Walgreens TRUEplus Pen Needles 5Bevel - 32G 4mm - - TRIVIDIA HEALTH, INC.

Duns Number:151810868

Device Description: Walgreens TRUEplus Pen Needles 5Bevel - 32G 4mm - 50ct box

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More Product Details

Catalog Number

S6001A32-50

Brand Name

TRUEplus

Version/Model Number

TRUEplus Pen Needles 5Bevel - 32G 4mm

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K180720,K180720,K180720

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

17836de8-e78a-4be7-affc-80cfdea7bcea

Public Version Date

August 03, 2022

Public Version Number

1

DI Record Publish Date

July 26, 2022

Additional Identifiers

Package DI Number

10311917136346

Quantity per Package

60

Contains DI Package

00311917136349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"TRIVIDIA HEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 22