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 ID: 00853048008015
• NIH Device Record Key: 19ec4403-6a51-4538-acb3-573d90ef1215
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ActiGraph
• Version Model Number: GT9X
• Company DUNS: 144830952
• Company Name: ACTIGRAPH L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853048008015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080545

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-12-28

On-Brand Devices [ActiGraph]

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