AtmosAir 9000X - AtmosAir 9000X Hybrid mattress - 880 X 2020 X - Arjohuntleigh AB

Duns Number:355804758

Device Description: AtmosAir 9000X Hybrid mattress - 880 X 2020 X 180 mm (35 X 80 X 7 in) - Top Cover Premium

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More Product Details

Catalog Number

-

Brand Name

AtmosAir 9000X

Version/Model Number

633038

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IKY

Product Code Name

Mattress, Flotation Therapy, Non-Powered

Device Record Status

Public Device Record Key

7a1ac8ab-9171-46a3-91eb-4e3df9f3e598

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARJOHUNTLEIGH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 420
2 A medical device with a moderate to high risk that requires special controls. 840