Catalog Number

-

Brand Name

Bag, Urine Collection, Leg, for External Use, Sterile, 20/Cs

Version/Model Number

4290

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KNX

Product Code Name

Collector, Urine, (And Accessories) For Indwelling Catheter

Public Device Record Key

283c4229-293b-44f6-9506-5ca37807dd27

Public Version Date

April 07, 2021

Public Version Number

4

DI Record Publish Date

September 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-