AccessGUDID - DEVICE: BETTER HOMES AND GARDENS (06971496040068)

GUDID

Device Identifier (DI) Information

Brand Name: BETTER HOMES AND GARDENS
Version or Model: BHF185385385004(EF853H-WM)
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Zhongshan Camry Electronic Co., Ltd.

Primary DI Number: 06971496040068
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545321288 *Terms of Use

Device Description: No description.

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?
64281	Densitometry body composition analyser	An electrically-powered stationary device intended to use whole-body densitometry to determine body composition (percent and absolute body fat, and fat-free mass) based on manually-entered subject demographic data (e.g., age, gender, height), body weight, and body volume. The system includes controls and display, a scale for body weight measurement, and a closable cabin-like chamber with pre-calibrated air pressure sensors for determining body volume using air displacement plethysmography (by the application of pressure-volume relationships).	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: 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: 0461dfd4-6276-46c1-a4d1-a281b0f53512
Public Version Date: June 11, 2020
Public Version Number: 1
DI Record Publish Date: June 03, 2020