Primary Device ID | 00643169315839 |
NIH Device Record Key | 688d8363-37f2-48af-a1c2-184c20b7f1c7 |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 560BC1 |
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 Celsius and 66 Degrees Celsius |
Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Storage Environment Temperature | Between -40 Degrees Celsius and 66 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169315839 [Primary] |
DWA | Control, pump speed, cardiopulmonary bypass |
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 | 2015-06-19 |
20763000950280 - NA | 2024-05-07 CUSTOM PACK BB10N53R3 5PK ACCESSORY |
00763000950699 - NA | 2024-05-07 CUSTOM PACK 5D56R9 NEURO FLOWS |
00763000841591 - Cardioblate™ Gemini™-s | 2024-05-06 CARDIOBLATE GEMINI-S 49260 EN |
00763000949341 - NA | 2024-05-06 CUSTOM PACK BB12A73R5 AV LOOP |
20763000949369 - NA | 2024-05-06 CUSTOM PACK BB12F71R2 4PK LOYOLA CPG |
00763000949372 - NA | 2024-05-06 CUSTOM PACK BB11L23R8 UTMC SUPP PK |
20763000950105 - NA | 2024-05-06 CUSTOM PACK BB12G65R 5PK TAPER |
00763000950118 - NA | 2024-05-06 CUSTOM PACK CB3Z71R24 PRIMARY |