Identity
- Trade Name
- Rescuer II Compact CPAP System FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- The Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. This disposable CPAP device is intended to be used on patient exhibiting signs of respiratory distress. The 8805 model is the device which comes with a Medium CPAP mask. FDA UDI
- Model / Reference
- 8805 FDA UDI
- Description
- The Rescuer II Compact CPAP System is a more compact version of the Rescuer Emergency CPAP System. This disposable CPAP device is intended to be used on patient exhibiting signs of respiratory distress. The 8805 model is the device which comes with a Medium CPAP mask. FDA UDI
Identifiers
- Catalog Number
- 8805 FDA UDI
- Primary DI / UDI-DI
- B00288050 FDA UDI
- 510(k) Number
- K122610 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5965 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
Yes
FDA UDI
Category: CPAP/BPAP face mask, single-use
Rescuer II Compact CPAP System by B.L.S. Systems Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP face mask, single-use.
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- AF541 — Respironics, Inc. · Class II
- BiTrac SE Select — Pulmodyne Inc. · Class II
- Veraseal 3 Full Face Vented Mask, Small — Sleepnet Corporation · Class II
- Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult — Sleepnet Corporation · Class II
- AF531 — Respironics, Inc. · Class II
Cleared under the same submission
K122610 also covers:
- Rescuer 8700 Large Deluxe CPAP Mask Only — B.L.S. Systems Limited
- Rescuer CPAP Deluxe Medium CPAP Mask only — B.L.S. Systems Limited
- Rescuer CPAP Small Deluxe CPAP Mask only — B.L.S. Systems Limited
- Rescuer Emergency CPAP — B.L.S. Systems Limited
- Rescuer Emergency CPAP System — B.L.S. Systems Limited
- Rescuer Emergency CPAP System — B.L.S. Systems Limited
- Rescuer Emergency CPAP System — B.L.S. Systems Limited
- Rescuer Emergency CPAP System — B.L.S. Systems Limited
- Rescuer Emergency CPAP System — B.L.S. Systems Limited
- Rescuer Emergency CPAP with Medium CPAP Mask — B.L.S. Systems Limited
- Rescuer Emergency CPAP with Nebulizer Kit — B.L.S. Systems Limited
- Rescuer II Compact CPAP System — B.L.S. Systems Limited
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
- B.L.S. Systems Limited
Sources (1)
- FDA UDI ba934cba-8490-4e7e-b7e3-ebea7a3915b0 38 fields · synced May 30, 2026