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

In Commercial Distribution

Commercial Distribution End Date

-

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

54d1315d-5a79-4435-9207-73792f5b6157

Public Version Date

February 15, 2021

Public Version Number

1

DI Record Publish Date

February 05, 2021

Additional Identifiers

Package DI Number

10670482000460

Quantity per Package

1

Contains DI Package

00670482000463

Package Discontinue Date

-

Package Status

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