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MX40 Adapter 6-Lead + Masimo SpO2
EUDAMEDFDA UDIClass I (EU MDR)
Ref 989803204291
Identity
- Trade Name
- MX40 Adapter 6-Lead + Masimo SpO2 EUDAMEDMX40 Masimo Leadsets and Adapters FDA UDI
- Generic Name
- Electrocardiographic lead set, reusable FDA UDI
- Device Name
- Reusable Leadsets/ECG leads/SPO2 Cables EUDAMEDMX40 Adapter 6-Lead + Masimo SpO2. For use with MX Telemetry systems. Supports IntelliVue connector style disposable and reusable ECG leadsets and DIN prewired electrodes on the MX Telemetry Systems. Supports Masimo SpO2 accessories defined for MX Telemetry systems. 6 lead ECG + Masimo SET SpO2. Quantity 1, reusable. FDA UDI
- Model / Reference
- 989803204291 EUDAMEDMX40 Adapter 6-Lead + Masimo SpO2 FDA UDI
- Description
- MX40 Adapter 6-Lead + Masimo SpO2. For use with MX Telemetry systems. Supports IntelliVue connector style disposable and reusable ECG leadsets and DIN prewired electrodes on the MX Telemetry Systems. Supports Masimo SpO2 accessories defined for MX Telemetry systems. 6 lead ECG + Masimo SET SpO2. Quantity 1, reusable. FDA UDI
Identifiers
- Catalog Number
- 989803204291 FDA UDI
- Primary DI / UDI-DI
- 00884838091276 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM332SN EUDAMED
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Electrocardiographic lead set, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
MX40 Adapter 6-Lead + Masimo SpO2 by Philips Medical Systems — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0884838BM332SN | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Philips Medical Systems
- EUDAMED SRN
- US-MF-000002321
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (2)
- EUDAMED 6df5ddb4-6f87-4626-bc36-6967a6d25172 61 fields · synced Jul 22, 2026
- FDA UDI 8362eabc-2205-4051-927b-071c25adc813 36 fields · synced May 30, 2026