AccessGUDID - DEVICE: Basic American Medical Products (M368ZZ786741)

GUDID

Device Identifier (DI) Information

Brand Name: Basic American Medical Products
Version or Model: ZZ78674
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GF HEALTH PRODUCTS, INC.

Primary DI Number: M368ZZ786741
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 114107329 *Terms of Use

Device Description: Zenith 8000 Slide W-I-D-E Bed

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":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
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?
34870	Basic electric hospital bed	A mains electricity (AC-powered) bed designed to be used as a patient bed for rest/sleep in a hospital ward/room, and which is motorized providing the patient/nursing staff with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard, siderails, and a remote control to operate the electrical motors. It may have an integrated weighing scale.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FNL	Bed, Ac-Powered Adjustable Hospital

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: 07105a94-c646-41e3-9e98-a5b70d6d7e41
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 31, 2016