Cerner Motion Health - CERNER CORPORATION

Duns Number:042410688

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More Product Details

Catalog Number

-

Brand Name

Cerner Motion Health

Version/Model Number

MotionHealth2016.22

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 24, 2018

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

ISD

Product Code Name

Exerciser, Measuring

Device Record Status

Public Device Record Key

2148aa6f-d49a-4587-a278-dd9df7953c56

Public Version Date

June 26, 2018

Public Version Number

4

DI Record Publish Date

July 27, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CERNER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 19