Bio-Medicus®
GUDID 00613994504616
CANNULA 96670-021 BIO-MEDICUS 21FR EA
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, femoral| Primary Device ID | 00613994504616 |
| NIH Device Record Key | adfb976a-1052-46de-a606-2fc9ab086fee |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Bio-Medicus® |
| Version Model Number | 96670-021 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Catheter Gauge | 21 French |
| Catheter Gauge | 21 French |
| Catheter Gauge | 21 French |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
| Length | 50 Centimeter |
| Catheter Gauge | 21 French |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
| Special Storage Condition, Specify | Between 0 and 0 *Do not store Carmeda® coated product over 40° C. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994504616 [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 | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-23 |
On-Brand Devices [Bio-Medicus®]
| 00613994622549 | CANN CB96345-023 BIO-MED 23FR |
| 00613994622532 | CANN CB96345-025 BIO-MED 25FR |
| 00613994622525 | CANN CB96345-027 BIO-MED 27FR |
| 00613994622518 | CANN CB96345-029 BIO-MED 29FR |
| 00613994622501 | CANN CB96570-015 BIO-MEDICUS 15FR |
| 00613994622495 | CANN CB96570-017 BIO-MEDICUS 17FR |
| 00613994622488 | CANN CB96570-019 BIO-MEDICUS 19FR |
| 00613994622471 | CANN CB96570-021 BIO-MEDICUS 21FR |
| 00613994622464 | CANN CB96670-015 BIO-MEDICUS 15FR |
| 00613994622457 | CANN CB96670-017 BIO-MEDICUS 17FR |
| 00613994622440 | CANN CB96670-019 BIO-MEDICUS 19FR EA |
| 00613994622433 | CANN CB96670-021 BIO-MEDICUS 21FR |
| 00613994608581 | CANNULA CB96535-015 BIO-MED 15FR ART KIT |
| 00613994608574 | CANNULA CB96535-017 BIO-MED 17FR ART KIT |
| 00613994608567 | CANNULA CB96535-019 BIO-MED 19FR ART KIT |
| 00613994608550 | CANNULA CB96535-021 BIO-MED 21FR ART KIT |
| 00613994608543 | CANNULA CB96540-023 BIO-MED 23FR ART KIT |
| 00613994608536 | CANNULA CB96605-015 BIO-MED 15FR VEN KIT |
| 00613994608529 | CANNULA CB96605-017 BIO-MED 17FR VEN KIT |
| 00613994608512 | CANNULA CB96605-019 BIO-MED 19FR VEN KIT |
| 00613994608505 | CANNULA CB96605-021 BIO-MED 21FR VEN KIT |
| 00613994608499 | CANNULA CB96605-023 BIO-MED 23FR VEN KIT |
| 00613994608475 | CANNULA CB98005-138 BIO-MED 23FR VEN KIT |
| 00613994608468 | CANNULA CB98005-139 BIO-MED 15FR ART KIT |
| 00613994608451 | CANNULA CB98005-140 BIO-MED 17FR VEN KIT |
| 00613994608444 | CANNULA CB98805-102 BIO-MED 14ART 0 HOLE |
| 00613994608437 | CANNULA CB98805-103 BIO-MED 12ART 0 HOLE |
| 00613994608420 | CANNULA CB98805-104 BIO-MED 10FR VEN KIT |
| 00613994608413 | CANNULA CB98805-105 BIO-MED 12FR VEN KIT |
| 00613994608406 | CANNULA CB98805-106 BIO-MED 14FR VEN KIT |
| 00613994530813 | CANNULA 96830-014 BIO-MED VEN 14F EA 17L |
| 00613994530806 | CANNULA 96830-012 BIO-MED VEN 12F EA 17L |
| 00613994530790 | CANNULA 96830-010 BIO-MED VEN 10F EA 17L |
| 00613994530783 | CANNULA 96830-008 BIO-MED VEN 8FR EA 17L |
| 00613994530738 | CANNULA 96820-014 BIO-MED ART 14F EA 17L |
| 00613994530721 | CANNULA 96820-012 BIO-MED ART 12F EA 17L |
| 00613994530714 | CANNULA 96820-010 BIO-MED ART 10F EA 17L |
| 00613994530707 | CANNULA 96820-008 BIO-MED ART 8FR EA 17L |
| 00613994530677 | CANNULA 98800-142 BIO-MED ART 14F EA 17L |
| 00613994530660 | CANNULA 98800-140 BIO-MED ART 12F EA 17L |
| 00613994530653 | CANNULA 98800-131 BIO-MED VEN 10F LL CON |
| 00613994530646 | CANNULA 98800-130 BIO-MED VEN 8F LL CONN |
| 00613994530639 | CANNULA 98800-128 BIO-MED ART 12F LL CON |
| 00613994530622 | CANNULA 98800-126 BIO-MED ART 8F LL CON |
| 00613994530615 | CANNULA 98800-115 BIO-MED VEN 14F LL CON |
| 00613994530608 | CANNULA 98800-110 BIO-MED ART 12F LL CON |
| 00613994530592 | CANNULA 98800-109 BIO-MED ART 10F LL CON |
| 00613994530585 | CANNULA 98800-108 BIO-MED ART 8F LL CON |
| 00613994504845 | CANNULA 96570-021 BIO-MEDICUS 21FR EA |
| 00613994504838 | CANNULA 96570-019 BIO-MEDICUS 19FR EA |
Trademark Results [Bio-Medicus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIO-MEDICUS 73000905 1036146 Live/Registered |
BIO-MEDICUS, INC. 1973-09-13 |
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