CirQPOD Intrathoracic Pressure Regulator
Basic Information
- Brand Name
- CirQPOD Intrathoracic Pressure Regulator
- Primary DI
- M5921224150000
- Version / Model
- 12-2415-000
- Company Name
- ADVANCED CIRCULATORY SYSTEMS INC
- Labeler DUNS
- 140320396
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-23
- Public Version
- 1
- Public Version Date
- 2018-09-24
- Public Version Status
- New
- Public Device Record Key
- 507cf244-da4e-4f1f-9d38-97ce307e7204
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BWF | Spirometer, Therapeutic (Incentive) | Anesthesiology | 868.5690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58941 | Cardiopulmonary resuscitation impedance valve, inspiratory | A non-sterile valve intended to increase blood flow to the heart and brain of a patient during cardiopulmonary resuscitation (CPR) by selectively impeding inspiratory gases during the release phase of CPR resulting in increased negative pressure in the thorax, greater venous return to the heart, and increased blood flow during the next compression. It is designed to connect between a ventilation source (e.g., pulmonary resuscitator) and an airway adjunct (e.g., face mask, breathing tube) and is typically comprised of a valve diaphragm (e.g., silicone) with a ventilation port and supplemental features [e.g., safety mechanism, visual metronome (battery-powered)]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M5921224150000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172388 | 000 |