Catalog Number

150507

Brand Name

Leg Bag

Version/Model Number

150507

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

NNW

Product Code Name

BAG, URINE COLLECTION, LEG, FOR EXTERNAL USE, NON-STERILE

Public Device Record Key

ad146066-5ada-4275-b177-6e845f4b42a1

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

September 23, 2020

Package DI Number

10801741050814

Quantity per Package

24

Contains DI Package

00801741050817

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA