AccessGUDID - DEVICE: Healthweigh (00850042373125)

GUDID

Device Identifier (DI) Information

Brand Name: Healthweigh
Version or Model: SD-1150-WP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 150707
Company Name: Rice Lake Weighing Systems, Inc.

Primary DI Number: 00850042373125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 023526783 *Terms of Use

Device Description: Scale, SD-1150-WP 1000LB Package (Scale, Handrail, Indicator, Pit Frame) 36IN(W)X 36IN(L) X 3IN(H) With Smooth Top Anti Slip Rubber Surface, Side Access Junction Box, 36IN(H)X 30IN(W) Steel Painted Handrial And Mounting Hardware. Indicator. 10FT Homerun Cable With Connector For Indicator. 36 in. x 36 in. Pit frame. Includes 6 AA size Alkaline batteries.

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: 05c00d5c-2d13-42d1-8429-1d6dbe76e279
Public Version Date: December 20, 2022
Public Version Number: 1
DI Record Publish Date: December 12, 2022