AccessGUDID - DEVICE: Doran Scales (00850013361175)

GUDID

Device Identifier (DI) Information

Brand Name: Doran Scales
Version or Model: DS9100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DS9100
Company Name: DORAN SCALES, INC.

Primary DI Number: 00850013361175
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 Single Ramp, 100x0.1lb (454x0.05kg)

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: 9610a050-9d0c-4c26-83ce-e4b243c4e1f1
Public Version Date: June 08, 2022
Public Version Number: 1
DI Record Publish Date: May 31, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 630-879-1200
Email: sales@doranscales.com

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