K-2oem ALT-AIRE+ - Alternating Pressure with On-Demand Low Air Loss - KAP MEDICAL

Duns Number:135241342

Device Description: Alternating Pressure with On-Demand Low Air Loss Even Side Bolster Mattress, Standard UK S Alternating Pressure with On-Demand Low Air Loss Even Side Bolster Mattress, Standard UK System

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More Product Details

Catalog Number

K-2oem-UK-ESB

Brand Name

K-2oem ALT-AIRE+

Version/Model Number

K-2oem-UK-ESB

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

7bee6772-45de-40a8-961d-88329a290f3d

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 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