Identity
- Trade Name
- SpO2 Finger Adapter M-Flex FDA UDI
- Generic Name
- Pulse oximeter probe, reusable FDA UDI
- Model / Reference
- 5010049 FDA UDI
Identifiers
- Catalog Number
- 5010049 FDA UDI
- Primary DI / UDI-DI
- EMIP50100491 FDA UDI
- 510(k) Number
- K142032 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Pulse oximeter probe, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
No
FDA UDI
MR Conditional FDA UDI
Category: Pulse oximeter probe, reusable
SpO2 Finger Adapter M-Flex by MIPM Mammendorfer Institut für Physik und Medizin GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Cleared under the same submission
K142032 also covers:
- CO2 Adult Nasal Line — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Airway Adapter — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Monitoring Line M/M — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- CO2 Water Trap — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Core — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Core — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Fiber Optic Temperature Sensor Surface — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Gas Sample Line Set — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- Gating Cable - Siemens — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (BD/Ohmeda - Argon Medical) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (BD/Ohmeda - Argon Medical) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
- IBP Interface cable (Edwards / Baxter - Edwards Lifesciences) — MIPM Mammendorfer Institut für Physik und Medizin GmbH
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 57048844-f938-4eb5-98c8-89a083ad26e1 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026