Micra™ AV2
GUDID 00763000078645
TPS MC2AVR1 MICRA AV2 US
MEDTRONIC, INC.
Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker Intracardiac pacemaker| Primary Device ID | 00763000078645 |
| NIH Device Record Key | d8992780-810d-457c-a795-9f77c1dc01cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micra™ AV2 |
| Version Model Number | MC2AVR1 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | true |
| Single Use | true |
| 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 |
Customer Support Contacts
| 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 | |
| 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 Dimensions
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
| Catheter Working Length | 105 Centimeter |
| Catheter Gauge | 23 French |
Operating and Storage Conditions
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
| Storage Environment Temperature | Between 77 Degrees Fahrenheit and 77 Degrees Fahrenheit |
| Handling Environment Temperature | Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000078645 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P150033
FDA Product Code
| PNJ | Leadless pacemaker |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-15 |
| Device Publish Date | 2023-05-05 |
Devices Manufactured by MEDTRONIC, INC.
| 00763000951825 - NA | 2024-05-31 CUSTOM PACK SSBB12G88R STERILE SMPL |
| 00763000953423 - NA | 2024-05-31 CUSTOM PACK BB12F51R2 E ASSIST PACK |
| 00763000953614 - NA | 2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN |
| 00763000953621 - NA | 2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC |
| 00763000953638 - NA | 2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP |
| 00763000953645 - NA | 2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP |
| 20763000953663 - NA | 2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL |
| 00763000953676 - NA | 2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK |
Trademark Results [Micra]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICRA 86794383 not registered Live/Pending |
Nissan Jidosha Kabushiki Kaisha 2015-10-21 |
 MICRA 85715767 4568896 Live/Registered |
Medtronic, Inc. 2012-08-29 |
 MICRA 85646130 4584996 Live/Registered |
Medtronic, Inc. 2012-06-07 |
 MICRA 85373179 not registered Dead/Abandoned |
Shiela Nail Products, Inc. 2011-07-16 |
MICRA 85373179 not registered Dead/Abandoned |
J-mar International 2011-07-16 |
 MICRA 79048392 3492995 Dead/Cancelled |
CONTROLLI S.P.A. 2007-12-20 |
 MICRA 78363412 not registered Dead/Abandoned |
Microeconomic Consulting & Research Associates, Inc. 2004-02-05 |
 MICRA 77577332 3688412 Dead/Cancelled |
Nissan Jidosha Kabushiki Kaisha 2008-09-24 |
 MICRA 76438044 2715711 Dead/Cancelled |
KIDDE PRODUCTS LIMITED 2002-08-05 |
 MICRA 76303416 2741079 Dead/Cancelled |
Montegrappa 1912 S.p.A. 2001-08-22 |
 MICRA 75871337 2622792 Dead/Cancelled |
NISSAN JIDOSHA KABUSHIKI KAISHA 1999-12-14 |
 MICRA 75639758 not registered Dead/Abandoned |
NISSAN JIDOSHA KABUSHIKI KAISHA 1999-02-11 |
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