Catalog Number

BB-3038-1S

Brand Name

A Plus

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)

-

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

d76a098a-6d75-4a93-ad97-0c097b5d7b00

Public Version Date

October 27, 2022

Public Version Number

2

DI Record Publish Date

October 18, 2022

Package DI Number

80683534810015

Quantity per Package

72

Contains DI Package

00683534810019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case