Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11401

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

7fe97411-337f-40bd-aecf-968c00370b7d

Public Version Date

February 21, 2022

Public Version Number

2

DI Record Publish Date

October 11, 2021

Package DI Number

60368001114013

Quantity per Package

8

Contains DI Package

00368001114011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-