ECG Patient Cable - 5 Lead - 10' (304.8cm) – AAMI
by Datascope Corp United States EUDAMEDGUDID
Ref 0012-00-1812-01Model Cardiosave
Product code DSPEMDN C9080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number10607IABPaccessoriesBW | Date5 May 2023 | StatusActive |
| United States | GUDID listing GUDID | Number10607567112213 | Date19 Sep 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- ECG Patient Cable - 5 Lead - 10' (304.8cm) – AAMI EUDAMEDCable,ECG TRUNK,5L,3.3K,AAMI GUDID
- Generic Name
- Electrocardiographic lead set, reusable
- Device Name
- Cardiosave
- Model / Ref / Catalog
- Cardiosave, 0012-00-1812-01
- Primary DI / UDI-DI
- 10607567112213
- Basic UDI-DI
- 10607IABPaccessoriesBW
- FDA Product Code
- DSP
- EMDN Code
- C9080 Cardiocirculatory system devices - accessories not included in other classes
- GMDN Term
- Electrocardiographic lead set, reusable
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.3535
- Market of Registration
- Sweden
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000015587
- Authorised representative
- MAQUET Critical Care AB SE-AR-000001442
Other devices from Datascope Corp.
Properties & raw data
Show properties, registry sources and raw records
Other properties (22)
- 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: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No
Sources (2)
- EUDAMED 24ddca92-7a5e-44b5-bcb2-7b735de0e1c3
- FDA UDI 03edb162-98ba-4117-bf19-c014c38354db