ActiGraph

GUDID 00853048008015

The GT9X is a body worn device that measures and records physical movement associated with daily activity and sleep. The GT9X is intended for use in applications where quantifiable measurement and storage of physical movement is desired.

ACTIGRAPH L.L.C.

Kinesiology ambulatory recorder
Primary Device ID00853048008015
NIH Device Record Key19ec4403-6a51-4538-acb3-573d90ef1215
Commercial Distribution StatusIn Commercial Distribution
Brand NameActiGraph
Version Model NumberGT9X
Company DUNS144830952
Company NameACTIGRAPH L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100853048008015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ISDExerciser, Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-05
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

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