AccessGUDID - DEVICE: Detecto (00809161317800)

GUDID

Device Identifier (DI) Information

Brand Name: Detecto
Version or Model: 6857DHR-AC
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CARDINAL SCALE MANUFACTURING COMPANY

Primary DI Number: 00809161317800
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, DHR, AC 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?
37001	Patient-height measure	A device designed to measure the height of a patient. It can be, e.g., a wall-mounted graduated scale or a freestanding vertical graduated rod with an adjustable cross-piece that is placed on the top of the patient's head. It may provide analogue or digital readings.	Active	false
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

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: 20268757-df01-46f9-838e-ce10de241a4b
Public Version Date: November 07, 2019
Public Version Number: 1
DI Record Publish Date: October 30, 2019