circul pro, x-large

GUDID 10850033422082

The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for comfort. It can be worn on either hand. The ring has a retractable spring design, which automatically adjusts the tightness of the ring and fixates the sensor array to the wearer’s finger. The ring has advanced photoelectric signal detection and processing methods which detect and analyze blood oxygen saturation and pulse rate. The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions.

BodiMetrics, LLC

Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 10850033422082
• NIH Device Record Key: 6bec8b30-4348-4b7d-b579-4d69690d77d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: circul pro, x-large
• Version Model Number: O2-77-MX
• Company DUNS: 079854070
• Company Name: BodiMetrics, LLC
• Device Count: 1
• DM Exempt: true
• 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: true
• 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: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com
• Phone: 8447448800
• Email: info@bodimetrics.com

Device Dimensions

• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter
• Lumen/Inner Diameter: 23 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 107.4 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850033422085 [Primary]
GS1	10850033422082 [Package]; Contains: 00850033422085; Package: Case [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221361

FDA Product Code

• DQA: Oximeter

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: 2025-03-03
• Device Publish Date: 2025-02-21

Devices Manufactured by BodiMetrics, LLC

• 00850033422061 - circul pro, small: 2025-03-03 The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for com
• 20850033422089 - circul pro, large: 2025-03-03 The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for com
• 10850033422082 - circul pro, x-large: 2025-03-03The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for comfort. It can be worn on either hand. The ring has a retractable spring design, which automatically adjusts the tightness of the ring and fixates the sensor array to the wearer’s finger. The ring has advanced photoelectric signal detection and processing methods which detect and analyze blood oxygen saturation and pulse rate. The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions.
• 10850033422082 - circul pro, x-large: 2025-03-03 The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for com