Catalog Number

-

Brand Name

PRIMO/ASP MEDICAL

Version/Model Number

UPA4057

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

KME

Product Code Name

Bedding, Disposable, Medical

Public Device Record Key

3c438715-298c-4582-ad0b-77325003a709

Public Version Date

August 23, 2022

Public Version Number

1

DI Record Publish Date

August 15, 2022

Package DI Number

00840216118355

Quantity per Package

25

Contains DI Package

00840216117662

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case