Opal DataHub V2C

GUDID 00850067173038

The Opal DataHub V2C is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors.

APDM WEARABLE TECHNOLOGIES, INC.

Kinesiology ambulatory recorder

• Primary Device ID: 00850067173038
• NIH Device Record Key: a54c010b-c7f6-4350-b49a-f9c3396d0d5e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opal DataHub V2C
• Version Model Number: DataHub
• Company DUNS: 117550003
• Company Name: APDM WEARABLE TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com
• Phone: +18003092111
• Email: customercare@clario.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850067173038 [Primary]

FDA Product Code

• ISD: Exerciser, Measuring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-09-09
• Device Publish Date: 2024-08-30

Devices Manufactured by APDM WEARABLE TECHNOLOGIES, INC.

• 00850067173007 - Opal V2C: 2024-09-09 Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monito
• 00850067173014 - Docking Station V2C: 2024-09-09 Docking Station V2C is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally, the
• 00850067173021 - Access Point V2C: 2024-09-09 Access Point V2C is an accessory that enables wireless streaming to a computer for the Opal V2C.
• 00850067173038 - Opal DataHub V2C: 2024-09-09The Opal DataHub V2C is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server where the files are processed. Additionally, the Opal DataHub recharges the battery of the Opal V2C sensors.
• 00850067173038 - Opal DataHub V2C: 2024-09-09 The Opal DataHub V2C is an accessory that extracts raw sensor data from the Opal V2C sensors and uploads it to a remote server w