Duns Number:140320396
Device Description: The CirQPOD Intrathoracic Pressure Regulator (IPR) System provides IPR therapy, intended t 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.
Catalog Number
-
Brand Name
CirQPOD Intrathoracic Pressure Regulator
Version/Model Number
12-2415-000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172388
Product Code
BWF
Product Code Name
Spirometer, Therapeutic (Incentive)
Public Device Record Key
507cf244-da4e-4f1f-9d38-97ce307e7204
Public Version Date
September 24, 2018
Public Version Number
1
DI Record Publish Date
August 23, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |