FDA UDI
In Commercial Distribution
🇺🇸 United States
CLAB II Plus Amplifier
DI: 00840682119634
·
Model: 64 Channel
·
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CLAB II Plus Amplifier
- Primary DI
- 00840682119634
- Version / Model
- 64 Channel
- Company Name
- GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
- Labeler DUNS
- 784985108
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 330854c5-b3fd-421f-8a75-5626d5d63f4a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 37807 | Cardiac catheterization monitoring system | An assembly of devices designed to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. It typically consists of a computerized central workstation including a monitor and a graphic recorder, and a slave monitor including patient interface modules in the catheterization laboratory. The system is used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches. | No | Active |
| 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 | 00840682119634 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130626 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 50 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 85 Percent (%) Relative Humidity