Catalog Number

HRLB500

Brand Name

TruCath

Version/Model Number

HRLB500

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FAQ

Product Code Name

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

Public Device Record Key

0f819891-03c4-45ac-9cca-835cea5fed46

Public Version Date

May 27, 2021

Public Version Number

1

DI Record Publish Date

May 19, 2021

Package DI Number

50850025153114

Quantity per Package

24

Contains DI Package

00850025153119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case