AccessGUDID - DEVICE: Medisante (04719878870016)

GUDID

Device Identifier (DI) Information

Brand Name: Medisante
Version or Model: BC800 3G
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EBM TECHNOLOGIES INCORPORATED

Primary DI Number: 04719878870016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 657261272 *Terms of Use

Device Description: BC800 3G Weight Scale is a digital monitor for home/domestic use which measures weight.

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":	Yes
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?
36020	Scale weight	A countermeasure that is produced in an exact unit of weight and intended to balance the weight of an object, typically on a mechanical scale, to produce a quantified measurement.	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: 38409ca4-8698-4a8c-9f16-3a1578b671c5
Public Version Date: September 01, 2020
Public Version Number: 1
DI Record Publish Date: August 24, 2020