airNEST orange HYBRID - Convertible air/foam Mattress System w. nylon - Umano Medical Inc

Duns Number:249675476

Device Description: Convertible air/foam Mattress System w. nylon cover 84"x35" and CT plate sleeve.

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More Product Details

Catalog Number

-

Brand Name

airNEST orange HYBRID

Version/Model Number

USTAOHYBS-843507N-CT-BIL

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

fb894de2-5696-4507-bf60-9660dc5218f9

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"UMANO MEDICAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 32