FDA Registration
Active
🇺🇸 United States
ECG Trunk Cables and Leadwires
Reg #: 3001570235
·
FEI: 3001570235
·
Expires 2025
Products
1
Proprietary Names
23
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE Medical Systems Information Technologies, Inc.
- Registration Number
- 3001570235
- FEI Number
- 3001570235
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3114 N Grandview Blvd.
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2018-06-06 |
Proprietary Names
ECG Trunk Cables and Leadwires
Trunk Cables (Cardiac Output Cables, Invasive Blood Pressure Cables, Temperature Cables)
ECG Adapter Cable
NOVII INTERFACE CABLE - GE UA
NOVII INTERFACE CABLE - GE MECG
MECG Cable
NOVII INTERFACE CABLE - GE FECG
Novii Cables (NOVII INTERFACE CABLE - GE FECG; NOVII INTERFACE CABLE - GE MECG; NOVII INTERFACE CABLE - GE UA)
FECG Cable
CLAB ECG Trunk Cable 12-lead IEC 10ft
4 Leadwire Expansion Cable, grabber, AHA, 74 cm/29 in.
Cable assembly ECG 3 lead neo AHA short, 1.8 m
CLAB ECG Trunk Cable 12-lead AHA 10ft
4 Leadwire Expansion Cable, snap, AHA, 130 cm/51 in.
4 Leadwire Expansion Cable, snap, IEC, 74 cm/29 in.
4 Leadwire Expansion Cable, grabber, IEC, 74 cm/29 in.
Cable assembly ECG 3 lead neo AHA long, 3.6 m
4 Leadwire Expansion Cable, grabber, IEC, 130 cm/51 in.
4 Leadwire Expansion Cable, snap, AHA, 74 cm/29 in.
4 Leadwire Expansion Cable, snap, IEC, 130 cm/51 in.
4 Leadwire Expansion Cable, grabber, AHA, 130 cm/51 in.
Cable assembly ECG 3 lead neo IEC short, 1.8 m
Cable assembly ECG 3 lead neo IEC long, 3.6 m
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility