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More Product Details

Catalog Number

-

Brand Name

CoachCare

Version/Model Number

S-3

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

a1181ac5-2310-4e46-9be3-eae3173f3ca0

Public Version Date

January 07, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2018

Additional Identifiers

Package DI Number

26947468545606

Quantity per Package

4

Contains DI Package

16947468545609

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

4pcs/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