Opal V2C OPALV2C

GUDID B628OPALV2C0

APDM's 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, INC.

Kinesiology ambulatory recorder

• Primary Device ID: B628OPALV2C0
• NIH Device Record Key: e26423fe-a8bf-4ff8-9b2b-c849eed13404
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opal V2C
• Version Model Number: V2C
• Catalog Number: OPALV2C
• Company DUNS: 808473453
• Company Name: APDM, 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: 503-445-7757
• Email: support@apdm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B628OPALV2C0 [Primary]

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: 2
• Public Version Date: 2020-03-05
• Device Publish Date: 2019-12-30

Devices Manufactured by APDM, INC.

• B628APV2C0 - Access Point V2C: 2020-03-05 APDM’s Access Point is an accessory that enables wireless streaming to a computer for the Opal V2C.
• B628DSV2C0 - Docking Station V2C: 2020-03-05 APDM’s Docking Station is an accessory that transfers the raw sensor data logged to a computer for the Opal V2C. Additionally,
• B628OPALV2C0 - Opal V2C: 2020-03-05APDM's 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.
• B628OPALV2C0 - Opal V2C: 2020-03-05 APDM's Opal V2C is a small worn monitor designed for documenting physical movement associated with applications in physiological