AccessGUDID - DEVICE: Craftmatic Model 1 Base (00850021160142)

GUDID

Device Identifier (DI) Information

Brand Name: Craftmatic Model 1 Base
Version or Model: 4AW529
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CMMOD1
Company Name: Craftmatic Industries, Inc.

Primary DI Number: 00850021160142
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031431014 *Terms of Use

Device Description: No description.

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
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?
46365	Basic electric home bed	A mains electricity (AC-powered) motorized bed designed to be used in the home by a patient for rest/sleep, and that provides the occupant with touch button adjustment possibilities. It typically includes a framework with wheels, a mattress support platform that can articulate, a headboard and footboard and a remote control to operate the electrical motors. The device typically raises the torso and/or legs to various heights. It may also include a heatable mattress and physical therapy pulsators.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LLI	Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

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
Weight: 143 Pound
Length: 80 Inch
Width: 53 Inch
Height: 5 Inch

Device Record Status

Public Device Record Key: da2c2dad-47f5-47f3-b043-8bbf8785eaf3
Public Version Date: March 02, 2022
Public Version Number: 1
DI Record Publish Date: February 22, 2022