Actigraph

GUDID 00853048008008

The wGT3X-BT is a body worn device that measures and records physical movement associated with daily activity and sleep. The wGT3X-BT 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: 00853048008008
• NIH Device Record Key: 5d63ffd7-a71b-49b0-bc57-ee443362f8e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Actigraph
• Version Model Number: wGT3X-BT
• 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	00853048008008 [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