Identity
- Trade Name
- INFINITY NELLCOR SP02 POD X8 FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Model / Reference
- MS23997 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049098049306 FDA UDI
- 510(k) Number
- K082888 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 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: Patient monitoring system module, pulse oximetry
Infinity Nellcor Sp02 Pod X8 by Draeger Medical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient monitoring system module, pulse oximetry.
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- MasimoSET® IntelliVue Module signal extraction pulse oximeter — MASIMO CORPORATION · Class II
- HyperView — Hypermed Imaging, Inc. · Class II
- Kit, DPM4, DPM5, Nellcor SpO2 — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K082888 also covers:
- SPO2 INTERMEDIATE CABLE, 3M — Draeger Medical Systems, Inc.
- SPO2 NELLCOR POD KIT DELTA — Draeger Medical Systems, Inc.
- SPO2 NELLCOR POD KIT KAPPA — Draeger Medical Systems, Inc.
- SpO2 Intermediate Cable 1.2m — Draeger Medical Systems, Inc.
- SpO2 Nellcor Interm Cable, 1M — Draeger Medical Systems, Inc.
- SpO2 Nellcor Interm Cable, 2M — Draeger Medical Systems, Inc.
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
- Draeger Medical Systems, Inc.
Sources (1)
- FDA UDI f3191071-a9bb-4e3c-a9a0-5a1e0be0b0af 34 fields · synced Jun 9, 2026