Catalog Number

EB200

Brand Name

AllCare

Version/Model Number

EB200

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)

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

404edf0e-a040-4cdc-baab-55482c5dc7b7

Public Version Date

April 14, 2022

Public Version Number

1

DI Record Publish Date

April 06, 2022

Package DI Number

10182921000103

Quantity per Package

10

Contains DI Package

00182921000106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case