LogiCal
by ICU Medical, Inc. United States EUDAMEDGUDID
Ref MX961Z102
Product code DRSEMDN Z129099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0887709LogicalRCablesGF | Date19 Mar 2025 | StatusActive |
| United States | GUDID listing GUDID | Number50351688502290 | Date13 Oct 2016 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- LogiCal EUDAMEDMedex GUDID
- Generic Name
- Invasive-pressure external transducer, single-use
- Device Name
- Logical Reusable Cables
- Model / Reference
- MX961Z102
- Primary DI / UDI-DI
- 50351688502290
- Basic UDI-DI
- 0887709LogicalRCablesGF
- FDA Product Code
- DRS
- EMDN Code
- Z129099 Various instruments for functional exploration and therapeutic interventions - other
- GMDN Term
- Invasive-pressure external transducer, single-use
- Device Class
- Class I EUDAMEDClass II GUDID
- Regulation Number
- 870.2850
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class I | Class II |
Manufacturer details
- EUDAMED SRN
- US-MF-000009764
- Authorised representative
- ICU Medical BV NL-AR-000002748
Other devices from Icu Medical, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (21)
- 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
Sources (2)
- EUDAMED 68b3bdc7-75c8-40cd-bb1b-a6bdaf299e4b
- FDA UDI 05c172ae-48a0-48e3-aed7-9b292b405acd