AccessGUDID - DEVICE: Doran Scales (00850013361151)

GUDID

Device Identifier (DI) Information

Brand Name: Doran Scales
Version or Model: DS8030
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS8030
Company Name: DORAN SCALES, INC.

Primary DI Number: 00850013361151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021437579 *Terms of Use

Device Description: Wheelchair Scale with Dual Ramp and Mast 800x0.2lb (360x0.1kg) includes ULc approved, 110 VAC adapter

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?
15053	Wheelchair-accessible platform scale	An electronic device designed to measure the weight of a wheelchair occupant who is unable to vacate their wheelchair; it may in addition be intended to function as a patient stand-on scale. It is designed as a floor-standing or floor-integrated platform whereby the known weight of the wheelchair is subtracted from the total measured weight to provide the weight of the wheelchair occupant; it is not designed to weigh a bed/stretcher.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
INF	Scale, Platform, Wheelchair

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: a057b799-53c0-4282-b4fe-33521b945c20
Public Version Date: June 08, 2022
Public Version Number: 1
DI Record Publish Date: May 31, 2022