Primary Device ID | 20643169794799 |
NIH Device Record Key | a1cc550e-52cb-468f-b533-d398d605f8ce |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Bio-Pump+™ |
Version Model Number | 95201 |
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 |
Lumen/Inner Diameter | 9.53 Millimeter |
Lumen/Inner Diameter | 9.53 Millimeter |
Lumen/Inner Diameter | 9.53 Millimeter |
Lumen/Inner Diameter | 9.53 Millimeter |
Lumen/Inner Diameter | 9.53 Millimeter |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169794795 [Primary] |
GS1 | 20643169794799 [Package] Contains: 00643169794795 Package: PK [4 Units] In Commercial Distribution |
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 | 2017-01-22 |
20643169794799 | PUMP 95201 BIO-PUMP BPX80 STER 3L 4PK |
00643169630581 | PUMP CBBPX-80 BIOPUMP 6HR CB ADULT ST 3L |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() BIO-PUMP+ 75594548 2532504 Dead/Cancelled |
Medtronic, Inc. 1998-11-24 |