ActiGraph - The CentrePoint Data Hub is a home-based - ACTIGRAPH L.L.C.

Duns Number:144830952

Device Description: The CentrePoint Data Hub is a home-based communication gateway that securely transmits dat The CentrePoint Data Hub is a home-based communication gateway that securely transmits data captured by ActiGraph activity monitors.

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More Product Details

Catalog Number

-

Brand Name

ActiGraph

Version/Model Number

CentrePoint Data Hub

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

OUG

Product Code Name

Medical Device Data System

Device Record Status

Public Device Record Key

94b7c6f5-86c5-4d25-affe-5b37570b3048

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 28, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACTIGRAPH L.L.C." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 3