Freedom 500 - Medical bed. - Umano Medical Inc

Duns Number:249675476

Device Description: Medical bed.

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More Product Details

Catalog Number

FM500

Brand Name

Freedom 500

Version/Model Number

FM500

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 03, 2021

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

FNL

Product Code Name

Bed, Ac-Powered Adjustable Hospital

Device Record Status

Public Device Record Key

757e11d0-9b6b-4b35-93fd-af2680495d4d

Public Version Date

February 08, 2021

Public Version Number

4

DI Record Publish Date

January 10, 2018

Additional Identifiers

Package DI Number

10670482000125

Quantity per Package

1

Contains DI Package

00670482000128

Package Discontinue Date

February 03, 2021

Package Status

Not in Commercial Distribution

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