RITMED ASSUREWEAR - RITMED ASSUREWEAR Isolation Gown Level 2 - AMD Medicom Inc

Duns Number:256880576

Device Description: RITMED ASSUREWEAR Isolation Gown Level 2 Over-the-head, Yellow, X-Large

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More Product Details

Catalog Number

A69978

Brand Name

RITMED ASSUREWEAR

Version/Model Number

A69978

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

OEA

Product Code Name

Non-surgical isolation gown

Device Record Status

Public Device Record Key

cbb93261-be23-478a-bbbc-deec955728bd

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 2021

Additional Identifiers

Package DI Number

20686864057820

Quantity per Package

10

Contains DI Package

10686864057823

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER CASE

"AMD MEDICOM INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 84
2 A medical device with a moderate to high risk that requires special controls. 27
U Unclassified 2