Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Device Name
- Nonin Xpod 3012LP USB FDA UDI
- Model / Reference
- 6703-001 FDA UDI
- Description
- Nonin Xpod 3012LP USB FDA UDI
Identifiers
- Catalog Number
- 6703-001 FDA UDI
- Primary DI / UDI-DI
- 09420012470744 FDA UDI
- FDA Product Code
- QAV FDA UDI
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5454 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Patient monitoring system module, pulse oximetry
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — 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
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI 68e6bf5b-977e-4d5b-b401-4deef2e3e167 36 fields · synced Jun 1, 2026