AccessGUDID - DEVICE: AMFAB (00822383264653)

GUDID

Device Identifier (DI) Information

Brand Name: AMFAB
Version or Model: 13081-BC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Drive Devilbiss Healthcare

Primary DI Number: 00822383264653
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 867673159 *Terms of Use

Device Description: Patient Room Overbed Tables Product Description Biltmore Cherry OBT,Low Style,Chrome,1ea

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35395	Overbed table	A table designed to be moved directly over the bed of a patient/occupant to provide them with a surface to eat, read, or write while in bed. It is typically constructed as a C-shaped metal framework with a table top surface, on which objects are placed, and small Castor wheels to provide the mobility for moving it over the bed.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INW	TABLE, MECHANICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 387a694d-e25d-402e-a539-959a2ffcb9e6
Public Version Date: February 10, 2020
Public Version Number: 1
DI Record Publish Date: February 01, 2020