FDA UDI
In Commercial Distribution
🇺🇸 United States
HexaPulse™ PF Generator
DI: 00763000871925
·
Model: AFR-00008
·
MEDTRONIC, INC.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HexaPulse™ PF Generator
- Primary DI
- 00763000871925
- Version / Model
- AFR-00008
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-11-04
- Public Version
- 1
- Public Version Date
- 2024-11-12
- Public Version Status
- New
- Public Device Record Key
- 824ee69a-e8a4-46ab-ac2a-68f770c2d103
Device Description
GENERATOR AFR-00008 HEXAPULSE PF US
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 |
|---|---|---|---|---|
| OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation | Unknown | 3 | |
| QZI | Percutaneous Cardiac Ablation Catheter for Treatment of Atrial Fibrillation with Irreversible Electroporation | Unknown | 3 | |
| OAD | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65067 | Cardiac irreversible electroporation system generator | A cardiac-dedicated mains electricity (AC-powered) device designed to generate microsecond electrical pulses to produce irreversible cell membrane electroporation (a phenomenon that induces cell membrane pores to open resulting in loss of homeostasis and subsequent cell death) for the selective nonthermal ablation of cardiac tissues. It includes controls (e.g., foot-switch), user interface, and is designed to connect to appropriate cardiac mapping equipment and catheter (not included). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00763000871925 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P240013 | 000 |