truME - D321077 - Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.

Duns Number:529903321

Device Description: D321077

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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

MR Safe

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

d837cd8e-a94a-46ff-b5f8-ddd63465e5e4

Public Version Date

January 10, 2022

Public Version Number

1

DI Record Publish Date

December 31, 2021

Additional Identifiers

Package DI Number

16947468500257

Quantity per Package

1

Contains DI Package

06947468500359

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"SHENZHEN BELTER HEALTH MEASUREMENT AND ANALYSIS 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. 25