K-6 TURN-ZONE - Alternating Pressure, Rotation, Turn Assist, - KAP MEDICAL

Duns Number:135241342

Device Description: Alternating Pressure, Rotation, Turn Assist, On-Demand Low Air Loss, Vinyl black base, Mat Alternating Pressure, Rotation, Turn Assist, On-Demand Low Air Loss, Vinyl black base, Mattress System 84"x 36"x11".

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More Product Details

Catalog Number

U-K-6-MS-84-D

Brand Name

K-6 TURN-ZONE

Version/Model Number

U-K-6-MS-84-D

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"

-

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

IKZ

Product Code Name

Bed, Patient Rotation, Powered

Device Record Status

Public Device Record Key

f09bced3-02ad-4a94-a81b-10bee69e7409

Public Version Date

September 29, 2021

Public Version Number

1

DI Record Publish Date

September 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KAP MEDICAL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1029