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More Product Details

Catalog Number

-

Brand Name

Contact Health

Version/Model Number

EF-802B4

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

abbe6392-cbbe-43c3-82b8-f24ba395c338

Public Version Date

January 20, 2021

Public Version Number

1

DI Record Publish Date

January 12, 2021

Additional Identifiers

Package DI Number

16947468500127

Quantity per Package

1

Contains DI Package

06947468500120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1pcs/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