K-4 D³X - Alternating Pressure, Low Air Loss, Variable - KAP MEDICAL

Duns Number:135241342

Device Description: Alternating Pressure, Low Air Loss, Variable Length, Mattress System, 80"~85"~90"x 36" x 8 Alternating Pressure, Low Air Loss, Variable Length, Mattress System, 80"~85"~90"x 36" x 8"

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More Product Details

Catalog Number

K-4MS8X88

Brand Name

K-4 D³X

Version/Model Number

K-4MS8X88

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

38d9f4ec-8493-4c2d-832a-fdfea6df95e3

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 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