FDA UDI
In Commercial Distribution
🇺🇸 United States
CardioLab
DI: 00195278507044
·
Model: AltiX
·
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CardioLab
- Primary DI
- 00195278507044
- Version / Model
- AltiX
- Catalog Number
- 2300000-004
- Company Name
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Labeler DUNS
- 006580799
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-05-01
- Public Version
- 1
- Public Version Date
- 2022-05-09
- Public Version Status
- New
- Public Device Record Key
- 3710b3d0-c026-49fc-8ebb-5825a5974637
Device Description
Computer CardioLab Acquisition v8.0
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQK | Computer, diagnostic, programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17898 | Cardiac electrophysiology analysis system | An assembly of devices designed to perform several diagnostic tests and therapeutic treatments of the heart in patients with arrhythmic or conduction disorders. It typically consists of a computerized workstation including a monitor, a printer or graphic recorder, a data recorder (e.g., optical or magnetic disk), and plug-in modules for signal amplification and/or conditioning. Signals are taken from external electrodes on the chest as well as from intracardiac electrodes and from blood pressure transducers. Device uses include analysis of the atrioventricular conduction system, defibrillator function, and the induction/termination of ventricular tachycardia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00195278507044 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K213972 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 85 Percent (%) Relative Humidity