Primary Device ID | 00763000871895 |
NIH Device Record Key | 11dab6cf-ab43-4e16-a402-70dfafcf5c29 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HexaFlow™ Irrigation Pump |
Version Model Number | AFR-00005 |
Company DUNS | 006261481 |
Company Name | MEDTRONIC, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000871895 [Primary] |
OAE | Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-12 |
Device Publish Date | 2024-11-04 |
20763000825380 - NA | 2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG |
20763000984193 - NA | 2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG |
20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEXAFLOW 97880820 not registered Live/Pending |
Affera, Inc 2023-04-10 |