Infinity Masimo Spo2 Pod Usb
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- INFINITY MASIMO SP02 POD USB EUDAMEDINFINITY MASIMO SPO2 POD USB FDA UDI
- Generic Name
- Patient monitoring system module, pulse oximetry FDA UDI
- Model / Reference
- MS16358 EUDAMEDFDA UDI050739 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049098050739 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049098050739 EUDAMED
- 510(k) Number
- K061329 FDA UDI
- FDA Product Code
- DQA FDA UDI
- EMDN Code
- Z1203020408 PULSE OXIMETERS EUDAMED
- GMDN Term
- Patient monitoring system module, pulse oximetry FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Patient monitoring system module, pulse oximetry
Infinity Masimo Spo2 Pod Usb by Draeger Medical Systems, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, pulse oximetry.
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Cleared under the same submission
K061329 also covers:
- INFINITY MASIMO SPO2 POD X8 — Draeger Medical Systems, Inc.
- SPO2 INTERM CBL MASIMO LNOP, 3M — Draeger Medical Systems, Inc.
- SPO2 MASIMOSET POD SET KAPPA — Draeger Medical Systems, Inc.
- SPO2 MASIMOSET POD SET USB — Draeger Medical Systems, Inc.
- SPO2 MASIMOSET POD SET X8 — Draeger Medical Systems, Inc.
- SpO2 Cable Masimo LNOP 1.2m — Draeger Medical Systems, Inc.
- SpO2 Masimo Cable LNCS 1.2m — Draeger Medical Systems, Inc.
- SpO2 MasimoSET Pod Set - Kappa XLT — Draeger Medical Systems, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Draeger Medical Systems, Inc.
Sources (2)
- FDA UDI ebd493a9-154d-426a-8f74-5afd58df769a 34 fields · synced Jul 22, 2026
- EUDAMED 86cc58d5-b295-48ba-a056-1be1c561cd1e 61 fields · synced Jul 22, 2026