FDA UDI
In Commercial Distribution
🇺🇸 United States
Advisa SR MRI™ SureScan®
DI: 00763000059620
·
Model: A3SR01
·
MEDTRONIC, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Advisa SR MRI™ SureScan®
- Primary DI
- 00763000059620
- Version / Model
- A3SR01
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-10-20
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 0e0356e3-49bd-4e6a-8825-52b122677b3d
Device Description
IPG A3SR01 ADVISA SR MRI IS1 US
Device Characteristics
- Single Use
- Yes
- 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
- MR Conditional
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWP | Implantable pulse generator, pacemaker (non-CRT) | Unknown | 3 | |
| NVZ | Pulse generator, permanent, implantable | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47267 | Single-chamber implantable pacemaker, rate-responsive | A battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000059620 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P980035 | 445 |
| P980035 | 532 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 131 Degrees Fahrenheit