Catalog Number

-

Brand Name

AmerisourceBergen

Version/Model Number

11404

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 12, 2028

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

6f023eee-9341-4ab0-be98-e96f64464cd0

Public Version Date

October 27, 2022

Public Version Number

4

DI Record Publish Date

October 11, 2021

Package DI Number

60368001114044

Quantity per Package

10

Contains DI Package

00368001114042

Package Discontinue Date

January 12, 2028

Package Status

In Commercial Distribution

Package Type

Case