Opal V2C

GUDID 00850067173007

Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.

APDM WEARABLE TECHNOLOGIES, INC.

Kinesiology ambulatory recorder

• Primary Device ID: 00850067173007
• NIH Device Record Key: e177556b-cfe6-4776-bf2b-b4ab8bdf2fb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opal V2C
• Version Model Number: Opal V2C
• 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 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850067173007 [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: 2024-09-09Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological monitoring. The Opal V2C can be used in any instance where quantifiable analysis of physical motion is desirable.
• 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: 2024-09-09 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