CARESCAPE ONE MBZ323 ATO MODEL

CARESCAPE ONE MBZ323 ATO MODEL
CARESCAPE ONE - MBZ323

An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DQK

Device Name: Computer, Diagnostic, Programmable

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: 870.1425

Third Party Flag: Y

Medical Specialty: CV

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: MUD

Device Name: Oximeter, Tissue Saturation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: SU

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: Y

Medical Specialty: CV

Code: DPZ

Device Name: Oximeter, Ear

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: 870.2710

Third Party Flag: N

Medical Specialty: CV

Code: FLL

Device Name: Continuous Measurement Thermometer

Device Class: 2

Physical State: The device may be a patch that is applied on or a probe that is used with a patient. Patches may include adhesive backing to allow the device to adhere to the target location. Probes are used invasively or non-invasively and may be connected wired or wirelessly to a compatible monitor or other device.

Definition: A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device is a contact or non-contact thermometer indicated to measure a person’s temperature. Temperature may be measured continuously, at pre-specified intervals, or remotely at the request of the user. The device output is displayed either on the device or may be transferred to a compatible monitor or device via a wired or wireless connection.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The device may be used externally on a person’s skin, used invasively including inside the esophagus or rectum, or ingested.

Regulation Number: 880.2910

Third Party Flag: Y

Medical Specialty: HO

Code: DSK

Device Name: Computer, Blood-Pressure

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: 870.1110

Third Party Flag: Y

Medical Specialty: CV

Code: DPS

Device Name: Electrocardiograph

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: 870.2340

Third Party Flag: Y

Medical Specialty: CV

Code: DXN

Device Name: System, Measurement, Blood-Pressure, Non-Invasive

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: 870.1130

Third Party Flag: Y

Medical Specialty: CV

Code: QEM

Device Name: Cerebral Oximeter

Device Class: 2

Physical State: Light radiation transmitter and receiver with associated analytical hardware and software to process the signal

Definition: Oximeter to measure cerebral tissue saturation

Submission Type ID: 1

Review Panel: NE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Transmits light radiation at known wavelength(s) through blood to measure oxygen saturation based on the amount of reflected or scattered radiation

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Head, Skull, Brain

Regulation Number: 870.2700

Third Party Flag: N

Medical Specialty: CV

Code: DSJ

Device Name: Alarm, Blood-Pressure

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: 870.1100

Third Party Flag: Y

Medical Specialty: CV

Code: BZQ

Device Name: Monitor, Breathing Frequency

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: 868.2375

Third Party Flag: Y

Medical Specialty: AN

Code: CCK

Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 868.1400

Third Party Flag: Y

Medical Specialty: AN

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

Code: DSI

Device Name: Detector And Alarm, Arrhythmia

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: DRT

Device Name: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

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: 870.2300

Third Party Flag: Y

Medical Specialty: CV

Code: MLD

Device Name: Monitor, St Segment With Alarm

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

Device Id: 00195278288639

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A