Primary Device ID | 00643169630604 |
NIH Device Record Key | 0ca9f717-a143-46ba-bab3-1e6911e47612 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bio-Pump™ |
Version Model Number | CBBP50 |
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 | 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 |
Lumen/Inner Diameter | 6.35 Millimeter |
Lumen/Inner Diameter | 6.35 Millimeter |
Lumen/Inner Diameter | 6.35 Millimeter |
Lumen/Inner Diameter | 6.35 Millimeter |
Lumen/Inner Diameter | 6.35 Millimeter |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Storage Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Storage Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Storage Environment Temperature | Between -40 Degrees Celsius and 40 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Do not use alcohol or alcohol based fluids on any surface of this device |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169630604 [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 | 2017-01-03 |
20643169794775 | PUMP 95171 BIOPUMP BP50 STER 3L 4PK |
00643169630604 | PUMP CBBP50 BIOPUMP 6HR CB PED ST 3L |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
BIO-PUMP 76418171 2731695 Live/Registered |
Zefon International, Inc. 2002-06-10 |
BIO-PUMP 74455329 1854560 Dead/Cancelled |
Medtronic Bio-Medicus, Inc. 1993-11-08 |
BIO-PUMP 73074863 1045349 Live/Registered |
BIO-MEDICUS, INC. 1976-01-21 |