AccessGUDID - DEVICE: Detecto (00809161323504)

GUDID

Device Identifier (DI) Information

Brand Name: Detecto
Version or Model: 6856-C
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARDINAL SCALE MANUFACTURING COMPANY

Primary DI Number: 00809161323504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 007153505 *Terms of Use

Device Description: Bariatric Scale, Digital, 1000 lb x .2 lb / 450kg x .1 kg, 24" x 24" Platform, BT / WiFi

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?
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	Active	false
33255	Chair scale, electronic	A battery-powered device designed for weighing elderly and/or weak patients, patients with a disability, or patients undergoing a specific treatment (e.g., dialysis) who are unable to use a conventional floor scale. It is the form of a chair in which the patient sits and their weight subsequently measured and displayed. It is primarily used for routine patient weight checks, but is also used to continuously and accurately monitor body fluid gain and loss in dialysis patients. It is designed to provide accurate patient weight measurements regardless of patient position in the chair seat.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRI	Scale, Stand-On, Patient

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: 917321ea-74fa-4838-aae2-dfa188bb9a0a
Public Version Date: November 26, 2021
Public Version Number: 1
DI Record Publish Date: November 18, 2021