MedSurg Manual Bed - MedSurg Manual Bed - Umano Medical Inc

Duns Number:249675476

Device Description: MedSurg Manual Bed

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More Product Details

Catalog Number

FL23P

Brand Name

MedSurg Manual Bed

Version/Model Number

FL23P

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 08, 2017

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

FNJ

Product Code Name

Bed, Manual

Device Record Status

Public Device Record Key

f66d3085-0bf8-4240-ac46-b0a9e499c6e6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

20670482000023

Quantity per Package

2

Contains DI Package

00670482000029

Package Discontinue Date

November 08, 2017

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