Catalog Number

D-8010

Brand Name

AMD-RITMED DISTECH

Version/Model Number

D-8010

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

aa565c58-afbb-4d91-ae33-a1d84cf02791

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 17, 2019

Package DI Number

20686864053655

Quantity per Package

5

Contains DI Package

10686864053658

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case