FDA UDI
In Commercial Distribution
🇺🇸 United States
EMS-XL
DI: 07290102933082
·
Model: 64 Ch. Console System
·
MENNEN MEDICAL LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EMS-XL
- Primary DI
- 07290102933082
- Version / Model
- 64 Ch. Console System
- Catalog Number
- 965-100-046
- Company Name
- MENNEN MEDICAL LTD.
- Labeler DUNS
- 600019749
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3e8062c4-8d1c-4ec4-85da-ca61d4e1bc24
Device Description
Cardiac electrophysiology analysis system
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
- Yes
- 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 | 07290102933082 | GS1 |
Customer Contacts
- Phone
- +2152591020
- [email protected]