Catalog Number

-

Brand Name

Alleset

Version/Model Number

Model 50-AMBC02

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)

-

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

251e7e85-edb7-435e-8423-0b40716dda5f

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 24, 2021

Package DI Number

26931918163441

Quantity per Package

1

Contains DI Package

16931918163444

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton