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SleepWeaver Advance Pediatric - Mask Only - Leopard
FDA UDIClass II (US FDA UDI)
by Circadiance
Identity
- Trade Name
- SleepWeaver Advance Pediatric - Mask Only - Leopard FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- SleepWeaver Advance Pediatric Cloth Nasal PAP Mask Only - Leopard FDA UDI
- Model / Reference
- 101323 FDA UDI
- Description
- SleepWeaver Advance Pediatric Cloth Nasal PAP Mask Only - Leopard FDA UDI
Identifiers
- Catalog Number
- 101323 FDA UDI
- Primary DI / UDI-DI
- B036101323 FDA UDI
- 510(k) Number
- K151683 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
SleepWeaver Advance Pediatric - Mask Only - Leopard by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Circadiance
Sources (1)
- FDA UDI 3c243a8e-bcc3-48e9-b1af-177873a72aa4 37 fields · synced Jun 9, 2026