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CirQPOD Intrathoracic Pressure Regulator

FDA UDI

Class II (US FDA UDI)

by Advanced Circulatory Systems Inc

Identity

Trade Name
CirQPOD Intrathoracic Pressure Regulator FDA UDI
Generic Name
Cardiopulmonary resuscitation impedance valve, inspiratory FDA UDI
Device Name
The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended to increase circulation and blood pressure in non-spontaneously breathing patients. The CirQPOD employs a single use, disposable blower device connected to the CirQPOD Motor - used in combination with a ventilator source - to deliver a positive pressure breath (ventilation) to a patient. The CirQPOD’s mechanism of action derives from the physiologic principle that lower intrathoracic pressure will increase venous return to the heart. The increase in venous return results in increased cardiac output, circulation, and blood pressure. When inserted within a standard respiratory circuit between the patient and a ventilation source, the CirQPOD generates negative pressure during the expiratory phase to create sub-atmospheric intrathoracic pressure between the periods of positive pressure ventilations. FDA UDI
Model / Reference
12-2415-000 FDA UDI
Description
The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended to increase circulation and blood pressure in non-spontaneously breathing patients. The CirQPOD employs a single use, disposable blower device connected to the CirQPOD Motor - used in combination with a ventilator source - to deliver a positive pressure breath (ventilation) to a patient. The CirQPOD’s mechanism of action derives from the physiologic principle that lower intrathoracic pressure will increase venous return to the heart. The increase in venous return results in increased cardiac output, circulation, and blood pressure. When inserted within a standard respiratory circuit between the patient and a ventilation source, the CirQPOD generates negative pressure during the expiratory phase to create sub-atmospheric intrathoracic pressure between the periods of positive pressure ventilations. FDA UDI

Identifiers

Primary DI / UDI-DI
M5921224150000 FDA UDI
510(k) Number
K172388 FDA UDI
FDA Product Code
BWF FDA UDI
GMDN Term
Cardiopulmonary resuscitation impedance valve, inspiratory FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5690 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiopulmonary resuscitation impedance valve, inspiratory

CirQPOD Intrathoracic Pressure Regulator by Advanced Circulatory Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary resuscitation impedance valve, inspiratory.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Circulatory Systems Inc

Sources (1)

  • FDA UDI 507cf244-da4e-4f1f-9d38-97ce307e7204 34 fields · synced May 29, 2026