2A Wearable Biosensor

2A Wearable Biosensor
UbiqVue Multiparameter - UB2550

Device Description

An electrically-powered wearable device (e.g., skin patch) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiogram (ECG), haemoglobin oxygen saturation (Sp02), haematocrit] 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 or for remote monitoring (e.g., of dialysis patients) by a healthcare professional. This is a single-use device.

Environmental Conditions

Handling Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Handling Environment Temperature - Degrees Celsius

45.00
0.00

Special Storage Condition, Specify

For long-term storage of more than 30 days, maintain between 5 and 27 Degrees Celsius

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

45.00
0.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DRG

Device Name: Transmitters And Receivers, Physiological Signal, Radiofrequency

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2910

Third Party Flag: Y

Medical Specialty: CV

Code: FLL

Device Name: Thermometer, Electronic, Clinical

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.2910

Third Party Flag: Y

Medical Specialty: HO

Code: MHX

Device Name: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.1025

Third Party Flag: N

Medical Specialty: CV

Code: DQA

Device Name: Oximeter

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.2700

Third Party Flag: N

Medical Specialty: CV

Device Identifiers

Device Id: B353UB25502

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B353UB25501

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Small Box

Device Id: B353UB25501

Device Type: Primary

DeviceId Issuing Agency: HIBCC

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: B353UB25503

Device Type: Package

DeviceId Issuing Agency: HIBCC

Contains DI Number: B353UB25502

Package Quantity: 4

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Big Box