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CBL ECG 5lead Grabber, AAMI+SpO2, SPU, Tele
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 989803172051
Identity
- Trade Name
- CBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele EUDAMEDECG Electrodes FDA UDI
- Generic Name
- Electrocardiographic lead set, single-use FDA UDI
- Device Name
- IntelliVue MX40 Single-Patient-Use Cable EUDAMEDMX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/finger wrap sensor for patients (. 20 kg). Grabber leads, AAMI color coded (white mono color lead wires). Single Patient Use. Cable length: ECG = 85 cm (33.5 .), SpO2 = 2m (6,5 ft) 1 Sales unit = 20 patient cables. FDA UDI
- Model / Reference
- 989803172051 EUDAMEDCBL ECG 5lead Grabber,AAMI+SpO2,SPU,Tele FDA UDI
- Description
- MX40 Patient Cable consists of 5-wire ECG lead set with integrated SpO2 cable/finger wrap sensor for patients (. 20 kg). Grabber leads, AAMI color coded (white mono color lead wires). Single Patient Use. Cable length: ECG = 85 cm (33.5 .), SpO2 = 2m (6,5 ft) 1 Sales unit = 20 patient cables. FDA UDI
Identifiers
- Catalog Number
- 989803172051 FDA UDI
- Primary DI / UDI-DI
- 20884838013500 EUDAMEDFDA UDI
- Basic UDI-DI
- B-20884838013500 EUDAMED
- FDA Product Code
- DSI FDA UDI
- EMDN Code
- Z1203020202 TRANSPORTABLE/PORTABLE MULTI–PARAMETER PATIENT MONITORS EUDAMED
- GMDN Term
- Electrocardiographic lead set, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1025 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
CBL ECG 5lead Grabber, AAMI+SpO2, SPU, Tele by Philips Medical Systems — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20884838013500 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | 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 10bf613c-bd1c-4a1c-a7a2-d9bedafa1dce 61 fields · synced Jun 18, 2026
- FDA UDI e953dcb4-26e3-4d44-bb99-3aa38b42fa9e 36 fields · synced May 30, 2026