Catalog Number

AS409

Brand Name

AMSure® Pediatric Urine Collector

Version/Model Number

1

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

EXI

Product Code Name

Device, Paste-On For Incontinence, Sterile

Public Device Record Key

25a07abf-f185-441d-af35-5449e3ad7de5

Public Version Date

July 02, 2018

Public Version Number

1

DI Record Publish Date

June 01, 2018

Package DI Number

40704411008058

Quantity per Package

10

Contains DI Package

30704411008051

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case