Identity
- Trade Name
- Nuwave FDA UDI
- Generic Name
- Home CPAP/BPAP washer-disinfector (ozone) FDA UDI
- Device Name
- NUWAVE Power Supply and Cord FDA UDI
- Model / Reference
- USB-PWR-ADPT-KIT FDA UDI
- Description
- NUWAVE Power Supply and Cord FDA UDI
Identifiers
- Catalog Number
- USB-PWR-ADPT-KIT FDA UDI
- Primary DI / UDI-DI
- 00812970012064 FDA UDI
- FDA Product Code
- LRJ FDA UDI
- GMDN Term
- Home CPAP/BPAP washer-disinfector (ozone) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6890 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home CPAP/BPAP washer-disinfector (ozone)
Nuwave by Exceleron Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home CPAP/BPAP washer-disinfector (ozone).
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- Nuwave — EXCELERON MEDICAL, LLC · Class I
- Nuwave — EXCELERON MEDICAL, LLC · Class I
- Nuwave — EXCELERON MEDICAL, LLC · Class I
- Nuwave — EXCELERON MEDICAL, LLC · Class I
- Nuwave — EXCELERON MEDICAL, LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Exceleron Medical, Llc
Sources (1)
- FDA UDI 7d3feda4-c2ef-44ce-98f2-c941e2ae2fea 34 fields · synced May 30, 2026