Catalog Number

8025-C

Brand Name

RITMED

Version/Model Number

8025-C

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

OEA

Product Code Name

Non-surgical isolation gown

Public Device Record Key

0c8e3597-28ac-4ed9-a473-55437703f896

Public Version Date

June 02, 2020

Public Version Number

1

DI Record Publish Date

May 25, 2020

Package DI Number

20686864056403

Quantity per Package

5

Contains DI Package

10686864056406

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE