Select 3D® ll
GUDID 20643169486281
CANNULA 78424 SELECT 3D II 24FR 20PK 17L
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, arterial| Primary Device ID | 20643169486281 |
| NIH Device Record Key | a6c5c317-5fbf-4c99-96ec-3ce812931e48 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Select 3D® ll |
| Version Model Number | 78424 |
| Company DUNS | 006261481 |
| Company Name | MEDTRONIC, INC. |
| Device Count | 20 |
| 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 | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
| Catheter Gauge | 24 French |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169486287 [Unit of Use] |
| GS1 | 20643169486281 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043179
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 | 2016-06-13 |
Devices Manufactured by MEDTRONIC, INC.
| 20763000825380 - NA | 2024-11-20 CUSTOM PACK CB12B36R1 4PK DEL NIDO CPG |
| 20763000984193 - NA | 2024-11-18 CUSTOM PACK BB12F71R5 4PK LOYOLA CPG |
| 20763000982946 - NA | 2024-11-15 CUSTOM PACK BB12B46R2 10PK MANIFOLD |
| 00763000984007 - NA | 2024-11-15 CUSTOM PACK BB12D88R6 UW HEART LUNG |
| 00763000984021 - NA | 2024-11-15 CUSTOM PACK BB12H36R4 PUMP TABLE |
| 00763000984151 - NA | 2024-11-15 CUSTOM PACK BB12F08R2 SPECTRUM ADLT |
| 00763000984168 - NA | 2024-11-15 CUSTOM PACK BB12F26R4 MUNSTER FUS |
| 00763000984175 - NA | 2024-11-15 CUSTOM PACK BB12F66R6 1/4 EC PACK |
Trademark Results [Select 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SELECT 3D 75606299 2656807 Live/Registered |
Medtronic, Inc. 1998-12-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.