Identity
- Trade Name
- Curaplex FDA UDI
- Generic Name
- In-line CPAP set, nebulizing FDA UDI
- Device Name
- Airway CPAP Rescuer Emergency W/ Prem. Lg AD Mask & Neb T FDA UDI
- Model / Reference
- BLS-8700KIT FDA UDI
- Description
- Airway CPAP Rescuer Emergency W/ Prem. Lg AD Mask & Neb T FDA UDI
Identifiers
- Catalog Number
- BLS-8700KIT FDA UDI
- Primary DI / UDI-DI
- 00812277034721 FDA UDI
- FDA Product Code
- QBY FDA UDI
- GMDN Term
- In-line CPAP set, nebulizing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5273 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: In-line CPAP set, nebulizing
Curaplex by Bound Tree Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as In-line CPAP set, nebulizing.
- VYGON — Vygon Corp. · Class II
- Rescuer II Compact CPAP with Nebulizer Kit — B.L.S. Systems Limited · Class II
- CARevent CPAP — O-Two Medical Technologies Inc · Class II
- MACS — AIRON CORPORATION · Class II
- Rescuer II Compact CPAP System with Small Deluxe CPAP Mask and Nebulizer Kit — B.L.S. Systems Limited · Class II
- MACS — AIRON CORPORATION · Class II
- Rescuer II Compact CPAP System with Medium Deluxe CPAP Mask and Nebulizer Kit — B.L.S. Systems Limited · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bound Tree Medical, Llc
Sources (1)
- FDA UDI 04e16780-43e1-44a1-9a60-d5572050a977 34 fields · synced May 30, 2026