Identity
- Trade Name
- APOZA FDA UDI
- Generic Name
- Home CPAP/BPAP washer-disinfector (ozone) FDA UDI
- Model / Reference
- OzonyMED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719883751539 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home CPAP/BPAP washer-disinfector (ozone)
Apoza by Apoza Enterprise Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Apoza Enterprise Co., Ltd.
Sources (1)
- FDA UDI f4517c46-fc9b-4d92-8549-fa6c5b7c88ee 32 fields · synced May 30, 2026