Identity
- Trade Name
- ResQGARD FM Kit FDA UDI
- Generic Name
- Cardiopulmonary resuscitation kit, reusable FDA UDI
- Device Name
- The ResQGARD ITD 7 is indicated for the temporary increase in blood circulation. The device is used to enhance circulation by lowering intrathoracic pressure in spontaneously breathing patients who experience poor circulation and low blood flow that may be indicated by low blood pressure. The device functions by adding selective inspiratory airway impedance within the respiratory circuit. Airway impedance is experienced when the patient spontaneously inspires. Expiratory impedance is negligible. FDA UDI
- Model / Reference
- 12-0707-000 FDA UDI
- Description
- The ResQGARD ITD 7 is indicated for the temporary increase in blood circulation. The device is used to enhance circulation by lowering intrathoracic pressure in spontaneously breathing patients who experience poor circulation and low blood flow that may be indicated by low blood pressure. The device functions by adding selective inspiratory airway impedance within the respiratory circuit. Airway impedance is experienced when the patient spontaneously inspires. Expiratory impedance is negligible. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M5921207070000 FDA UDI
- FDA Product Code
- BWF FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation kit, reusable 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Cardiopulmonary resuscitation kit, reusable
ResQGARD FM Kit by Advanced Circulatory Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Advanced Circulatory Systems Inc
Sources (1)
- FDA UDI 382a91f4-10e5-42f9-a740-53b2c57c10e6 33 fields · synced May 30, 2026