truME - Guangzhou Daxin health technology Co.,Ltd

Duns Number:722481840

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More Product Details

Catalog Number

-

Brand Name

truME

Version/Model Number

DMD1048BLK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PUH

Product Code Name

Analyzer, Body Composition, Exempt

Device Record Status

Public Device Record Key

75d789fc-26e1-432e-9ee1-e19b4bf5e07a

Public Version Date

August 04, 2022

Public Version Number

1

DI Record Publish Date

July 27, 2022

Additional Identifiers

Package DI Number

16974239700547

Quantity per Package

1

Contains DI Package

06974239702742

Package Discontinue Date

July 27, 2022

Package Status

Not in Commercial Distribution

Package Type

-

"GUANGZHOU DAXIN HEALTH TECHNOLOGY CO.,LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6