FDA UDI
In Commercial Distribution
🇺🇸 United States
AngelMed Guardian IMD Model AMSG3-E
DI: 00850012625001
·
Model: 0212-2100-001#P16
·
Angel Medical Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AngelMed Guardian IMD Model AMSG3-E
- Primary DI
- 00850012625001
- Version / Model
- 0212-2100-001#P16
- Catalog Number
- 0212-2100-001#P16
- Company Name
- Angel Medical Systems, Inc.
- Labeler DUNS
- 171391779
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-03-03
- Public Version
- 1
- Public Version Date
- 2021-03-11
- Public Version Status
- New
- Public Device Record Key
- 97eddb46-2673-4d5a-a924-f945c231d2cf
Device Description
IMD AMSG3-E Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QBI | Acute coronary syndrome event detector | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47804 | Implantable cardiac monitor | A hermetically-sealed, electrically-powered device [an implantable cardiac monitor (ICM)] intended to be implanted to monitor, record, and store electrocardiographic signals to help diagnose and monitor cardiac arrhythmias and/or acute coronary syndrome (ACS) changes; it may have a vibratory alarm function and the data can be telemetrically transmitted to an external device for alarming the patient and/or remote data transmission. It is used for a patient who experiences unexplained cardiac-related symptoms and/or is at risk for cardiac arrhythmias and/or ACS events. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850012625001 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P150009 | 000 |