K-2 KARE-ZONE - Alternating Pressure, AutoSet, Pulsation, Auto - KAP MEDICAL

Duns Number:135241342

Device Description: Alternating Pressure, AutoSet, Pulsation, Auto Bolster, On-Demand Low Air Loss, Mattress S Alternating Pressure, AutoSet, Pulsation, Auto Bolster, On-Demand Low Air Loss, Mattress System, 80"x 39" x 8".

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More Product Details

Catalog Number

K-2-B-MS-39-8

Brand Name

K-2 KARE-ZONE

Version/Model Number

K-2-B-MS-39-8

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

FNM

Product Code Name

Mattress, Air Flotation, Alternating Pressure

Device Record Status

Public Device Record Key

e0776b64-4f96-4127-8f13-caf052edb627

Public Version Date

September 05, 2022

Public Version Number

1

DI Record Publish Date

August 26, 2022

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