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 |
00763000976408 - NA | 2024-09-24 CUSTOM PACK 6W69R14 ADULT PACK |
00763000976415 - NA | 2024-09-24 CUSTOM PACK BB10V39R5 PEDI Q |
00763000976422 - NA | 2024-09-24 CUSTOM PACK BB11D79R4 UCSFMB SUPPOR |
00763000976439 - NA | 2024-09-24 CUSTOM PACK BB10G17R10 E INFANT |
00763000976460 - NA | 2024-09-24 CUSTOM PACK BB7C02R27 PMP/TBL |
00763000974749 - NA | 2024-09-23 CUSTOM PACK BB10Y59R11 FUSION |
00763000974978 - NA | 2024-09-23 CUSTOM PACK BB11X52R6 PUMP TABLE V2 |
20763000975177 - NA | 2024-09-23 CUSTOM PACK BB12J41R 5PK VEN CAN STUB L |
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 |