Primary Device ID | 00643169312098 |
NIH Device Record Key | 65e36b89-39ee-4583-b42f-2897b0b0bec8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CardioSight™ Reader |
Version Model Number | 2020A2 |
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 |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169312098 [Primary] |
NVZ | Pulse generator, permanent, implantable |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2014-09-23 |
00763000004101 - NA | 2025-09-02 COMMUNICATOR TM90T0 TDD PROX |
00199150042050 - NA | 2025-09-01 CUSTOM PACK SSHY12R43R HLN BB8G55R1 |
00199150042104 - NA | 2025-09-01 CUSTOM PACK BB12R13R1 HLN SUTT PED |
00199150042111 - NA | 2025-09-01 CUSTOM PACK BB12Q88R1 HLN INF SUTTE |
00763000998271 - Affera™ Integrated Mapping System | 2025-09-01 MAP SYS AFR-00016 IMPEDANCE US PLX |
00199150042005 - NA | 2025-08-29 CUSTOM PACK BB7E29R28 EVL 3/8 |
00199150042012 - NA | 2025-08-29 CUSTOM PACK BB11L88R8 EVL SUPPRT SM |
00199150042029 - NA | 2025-08-29 CUSTOM PACK BB12P62R3 EVL 1/4 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CARDIOSIGHT 78843441 3255486 Live/Registered |
Medtronic, Inc. 2006-03-22 |
![]() CARDIOSIGHT 78470161 3069373 Live/Registered |
Medtronic, Inc. 2004-08-19 |