ActiGraph

GUDID 00853048008022

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

ACTIGRAPH L.L.C.

Ambulatory monitoring/recording system transceiver/cable
Primary Device ID00853048008022
NIH Device Record Key94b7c6f5-86c5-4d25-affe-5b37570b3048
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiGraph
Version Model NumberCentrePoint Data Hub
Company DUNS144830952
Company NameACTIGRAPH L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853048008022 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-12-28

On-Brand Devices [ActiGraph]

00853048008039The ActiGraph CentrePoint Insight Watch is a compact, battery-operated wearable activity recordi
00853048008022The CentrePoint Data Hub is a home-based communication gateway that securely transmits data capt
00853048008015The GT9X is a body worn device that measures and records physical movement associated with daily
00853048008008The wGT3X-BT is a body worn device that measures and records physical movement associated with d
00853048008053The ActiGraph LEAP™ is a small, worn activity monitor designed for documenting physical moveme

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.