Bio-Medicus™
GUDID 00643169969377
CANN CB96570-021 BIO-MEDICUS 21FR
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, femoral| Primary Device ID | 00643169969377 |
| NIH Device Record Key | 22ce8b3c-88da-41bf-be62-5df9ca249464 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-Medicus™ |
| Version Model Number | CB96570-021 |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Length | 18 Centimeter |
| Length | 18 Centimeter |
| Length | 18 Centimeter |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
| Catheter Gauge | 21 French |
| Length | 18 Centimeter |
Operating and Storage Conditions
| 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 |
| 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 |
| 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 |
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169969377 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K924642
FDA Product Code
| DWF | Catheter, cannula and tubing, vascular, cardiopulmonary bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-25 |
| Device Publish Date | 2018-11-24 |
On-Brand Devices [Bio-Medicus™]
| 00643169026025 | CANNULA 96600-127 BIO-MEDICUS 27FR EA |
| 00643169026018 | CANNULA 96600-129 BIO-MEDICUS 29FR EA |
| 00643169025967 | CANNULA 96670-123 BIO-MEDICUS 23FR EA |
| 00643169025844 | CANNULA 96530-115 BIO-MEDICUS 15FR EA |
| 00643169025837 | CANNULA 96530-117 BIO-MEDICUS 17FR EA |
| 00643169025820 | CANNULA 96530-119 BIO-MEDICUS 19FR EA |
| 00643169025813 | CANNULA 96530-121 BIO-MEDICUS 21FR EA |
| 00643169025806 | CANNULA 96530-123 BIO-MEDICUS 23FR EA |
| 00643169025790 | CANNULA 96530-125 BIO-MEDICUS 25FR EA |
| 00643169025783 | CANNULA 96570-115 BIO-MEDICUS 15FR EA |
| 00643169025721 | CANNULA 96600-115 BIO-MEDICUS 15FR EA |
| 00643169025714 | CANNULA 96600-117 BIO-MEDICUS 17FR EA |
| 00643169025707 | CANNULA 96600-119 BIO-MEDICUS 19FR EA |
| 00643169025691 | CANNULA 96600-121 BIO-MEDICUS 21FR EA |
| 00643169025684 | CANNULA 96600-123 BIO-MEDICUS 23FR EA |
| 00643169025677 | CANNULA 96600-125 BIO-MEDICUS 25FR EA |
| 00643169969377 | CANN CB96570-021 BIO-MEDICUS 21FR |
| 00643169969360 | CANN CB96570-019 BIO-MEDICUS 19FR |
| 00643169969353 | CANN CB96570-017 BIO-MEDICUS 17FR |
| 00643169969346 | CANN CB96570-015 BIO-MEDICUS 15FR |
| 00643169880856 | CANNULA 98000-106 BIO-MED FEM ART 23FR |
| 00643169880849 | CANNULA 98000-105 BIO-MED FEM ART 21FR |
| 00643169880795 | CANNULA 96570-021 BIO-MEDICUS 21FR EA |
| 00643169880788 | CANNULA 96570-019 BIO-MEDICUS 19FR EA |
| 00643169880771 | CANNULA 96570-017 BIO-MEDICUS 17FR EA |
| 00643169880764 | CANNULA 96570-015 BIO-MEDICUS 15FR EA |
| 00643169880719 | CANNULA 96530-021 BIO-MED ART 21FR 17L |
| 00643169880702 | CANNULA 96530-019 BIO-MED ART 19FR 17L |
| 00643169880696 | CANNULA 96530-017 BIO-MED ART 17FR 17L |
| 00643169880689 | CANNULA 96530-015 BIO-MED ART 15FR 17L |
| 00643169697553 | CANNULA CB98805-103 BIO-MED 12ART 0 HOLE |
| 00643169697546 | CANNULA CB98805-102 BIO-MED 14ART 0 HOLE |
| 00643169696815 | CANNULA CB98805-110 BIO VEN 8FR CEPHAL |
| 00643169696808 | CANNULA CB96835-014 BIO-MEDICUS 14FR |
| 00643169696792 | CANNULA CB96835-012 BIO-MEDICUS 12FR |
| 00643169696785 | CANNULA CB96835-010 BIO-MEDICUS 10FR |
| 00643169696778 | CANNULA CB96835-008 BIO-MEDICUS 8FR |
| 00643169696761 | CANNULA CB96825-014 BIO-MEDICUS 14F |
| 00643169696754 | CANNULA CB96825-012 BIO-MEDICUS 12FR |
| 00643169696747 | CANNULA CB96825-010 BIO-MEDICUS 10FR |
| 00643169696730 | CANNULA CB96825-008 BIO-MEDICUS 8FR |
| 00643169696723 | CANN CB96670-021 BIO-MEDICUS 21FR |
| 00643169696716 | CANN CB96670-019 BIO-MEDICUS 19FR EA |
| 00643169696709 | CANN CB96670-017 BIO-MEDICUS 17FR |
| 00643169696693 | CANN CB96670-015 BIO-MEDICUS 15FR |
| 00643169696686 | CANN CB96570-021 BIO-MEDICUS 21FR |
| 00643169696679 | CANN CB96570-019 BIO-MEDICUS 19FR |
| 00643169696662 | CANN CB96570-017 BIO-MEDICUS 17FR |
| 00643169696655 | CANN CB96570-015 BIO-MEDICUS 15FR |
| 00643169696648 | CANN CB96345-029 BIO-MED 29FR |
Trademark Results [Bio-Medicus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIO-MEDICUS 73000905 1036146 Live/Registered |
BIO-MEDICUS, INC. 1973-09-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.