Primary Device ID | 00763000002329 |
NIH Device Record Key | 61663b58-f890-4228-b18f-c76a099a18a0 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | CB5N73R15 |
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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
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 |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00763000002329 [Primary] |
KFM | Pump, blood, cardiopulmonary bypass, non-roller type |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-05-25 |
00763000443214 - NA | 2024-05-27 CABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR |
00763000465728 - NA | 2024-05-27 CABLE 2ACHC ACHIEVE ADVANCE 10-PIN DR |
00763000723293 - ClosureRFS™ | 2024-05-27 STYLET RFS2-6-12 CLOSUREFAST |
00763000849078 - Vanta™ AdaptiveStim™ | 2024-05-27 INS 977006 VANTA US EMAN CARDIO |
00763000852887 - Injex® | 2024-05-27 ACCESS 97791 INJEX BUMPY ANCHOR EMAN |
00763000852894 - Injex® | 2024-05-27 ACCESS 97792 INJEX BI-WING ANCHOR EMAN |
00763000905590 - Launcher™ | 2024-05-27 CATHETER LA6SCR40K LA 6F 55CM SCR40 |
00763000905606 - Launcher™ | 2024-05-27 CATHETER LA6MP1K LA 6F 55CM MP1 |