AccessGUDID - DEVICE: truME (06947468500359)

GUDID

Device Identifier (DI) Information

Brand Name: truME
Version or Model: DMD1048BLK
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Primary DI Number: 06947468500359
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 529903321 *Terms of Use

Device Description: D321077

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
36022	Bioelectrical body composition analyser	An electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUH	Analyzer, Body Composition, Exempt

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: d837cd8e-a94a-46ff-b5f8-ddd63465e5e4
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: December 31, 2021