Identity
- Trade Name
- Waveline Pro+ FDA UDI
- Generic Name
- Pulse oximeter, line-powered FDA UDI
- Model / Reference
- 60146NEST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815871021104 FDA UDI
- FDA Product Code
- DSI FDA UDICBS FDA UDIDQA FDA UDICCK FDA UDICCL FDA UDIDSK FDA UDIDSA FDA UDIMLD FDA UDIDSF FDA UDIFLL FDA UDICBR FDA UDICBQ FDA UDIMHX FDA UDIDRT FDA UDIDXN FDA UDI
- GMDN Term
- Pulse oximeter, line-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI868.1620 FDA UDI870.2700 FDA UDI868.1400 FDA UDI868.1720 FDA UDI870.1110 FDA UDI870.2900 FDA UDI870.2810 FDA UDI880.2910 FDA UDI868.1700 FDA UDI868.1500 FDA UDI870.2300 FDA UDI870.1130 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General-purpose multi-parameter bedside monitorPulse oximeter, line-powered
Waveline Pro+ by Avante — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Avante
Sources (1)
- FDA UDI 61042068-9800-4d7a-a32a-2c5ea7163506 33 fields · synced May 30, 2026