Action® - Combo Overlay W/Hitch - ACTION PRODUCTS, INC.

Duns Number:067543058

Device Description: Combo Overlay W/Hitch

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More Product Details

Catalog Number

6405H

Brand Name

Action®

Version/Model Number

Mattress Overlay

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

-

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 Details

Product Code

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Device Record Status

Public Device Record Key

ab766df1-c529-4b7f-9e69-de7bcb8b1e70

Public Version Date

February 11, 2021

Public Version Number

1

DI Record Publish Date

February 03, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACTION PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 993
2 A medical device with a moderate to high risk that requires special controls. 49