AMFAB - Patient Room Overbed Tables Product Description - Drive Devilbiss Healthcare

Duns Number:867673159

Device Description: Patient Room Overbed Tables Product Description OBTPnmCyl,GW,LowProfileFork,Chrm,Vanity

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More Product Details

Catalog Number

-

Brand Name

AMFAB

Version/Model Number

16008-LP-FCGWV

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"

Yes

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

INW

Product Code Name

TABLE, MECHANICAL

Device Record Status

Public Device Record Key

08123e8a-363e-49f3-b70e-f440fa62ad2f

Public Version Date

February 10, 2020

Public Version Number

1

DI Record Publish Date

February 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRIVE DEVILBISS HEALTHCARE" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3783
2 A medical device with a moderate to high risk that requires special controls. 832