Identity
- Trade Name
- Rescuer Emergency CPAP System FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Rescuer Emergency CPAP System with #6 cushion mask and silicone head strap used to deliver continuous positive airway pressure (CPAP) to patients with acute episodes of respiratory distress. FDA UDI
- Model / Reference
- 8750 FDA UDI
- Description
- Rescuer Emergency CPAP System with #6 cushion mask and silicone head strap used to deliver continuous positive airway pressure (CPAP) to patients with acute episodes of respiratory distress. FDA UDI
Identifiers
- Catalog Number
- 8750 FDA UDI
- Primary DI / UDI-DI
- B00287500 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 Emergency 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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- 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 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
- 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 60558357-4a9a-4f13-b56e-7d295a76c657 38 fields · synced Jun 1, 2026