FDA UDI
In Commercial Distribution
🇺🇸 United States
M12 System
DI: 00815187020754
·
Model: 000-400-0129
·
GLOBAL INSTRUMENTATION, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- M12 System
- Primary DI
- 00815187020754
- Version / Model
- 000-400-0129
- Catalog Number
- 000-400-0129
- Company Name
- GLOBAL INSTRUMENTATION, LLC
- Labeler DUNS
- 147035427
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-03
- Public Version
- 1
- Public Version Date
- 2024-12-11
- Public Version Status
- New
- Public Device Record Key
- c0933f61-8de3-4806-891a-3a12485d8d3e
Device Description
SD Card (GI Label)
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
- 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 |
|---|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35162 | Electrocardiographic ambulatory recorder | An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00815187020754 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051730 | 000 |