K-3 AIRE-ZONE - Pulsation, True Low Air Loss 36"~42"~48" Wide, - KAP MEDICAL

Duns Number:135241342

Device Description: Pulsation, True Low Air Loss 36"~42"~48" Wide, 80"~85"~90" Long Expandable Mattress, Baria Pulsation, True Low Air Loss 36"~42"~48" Wide, 80"~85"~90" Long Expandable Mattress, Bariatric UK System

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More Product Details

Catalog Number

K-3-UK-XMS

Brand Name

K-3 AIRE-ZONE

Version/Model Number

K-3-UK-XMS

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

IOQ

Product Code Name

Bed, Flotation Therapy, Powered

Device Record Status

Public Device Record Key

d1e72d42-1124-4625-8f30-e6db82136ac6

Public Version Date

July 03, 2020

Public Version Number

1

DI Record Publish Date

June 25, 2020

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