FDA.report

BETTER HOMES AND GARDENS

Primary DI
06971496040068
Brand
BETTER HOMES AND GARDENS
Company
Zhongshan Camry Electronic Co., Ltd.
Model
BHF185385385004(EF853H-WM)
Published
2020-06-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971496040068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971496040068069714960400686971496040068

GMDN Terms

TermDefinition
Densitometry body composition analyserAn 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).

Sterilization Methods

Method

Regulatory Flags

DUNS number
545321288
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
06971496040051BETTER HOMES AND GARDENSBHF195095095002(EF856H-WM)2020-06-03

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