circul pro, x-large

Primary DI
00850033422085
Brand
circul pro, x-large
Company
BodiMetrics, LLC
Model
O2-77-MX
Device description
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.
Published
2025-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221361000circul™ pro RingBodimetrics, LLC2023-08-29DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850033422082PackageGS1100In Commercial Distribution
00850033422085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085003342208210850033422082
00850033422085008500334220858500334220850850033422085

GMDN Terms#

Term, Definition table
TermDefinition
Wearable multiple physiological parameter recorder, reusableAn electrically-powered wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a smart device or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter23Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal107.4 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8447448800info@bodimetrics.com

Regulatory Flags#

DUNS number
079854070
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850033422078circul pro, largeO2-77-ML2025-02-21
00850033422061circul pro, smallO2-77-MS2025-02-21
20850033422089circul pro, largeO2-77-ML2025-02-21
10850033422082circul pro, x-largeO2-77-MX2025-02-21

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