Select 3D™ II
GUDID 00643169561090
CANN CB78422 SELECT 3D II 22FR 17L
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, arterial| Primary Device ID | 00643169561090 |
| NIH Device Record Key | 5c9dd98b-6895-4328-beb2-27c0ace7a26b |
| Commercial Distribution Discontinuation | 2018-07-05 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Select 3D™ II |
| Version Model Number | CB78422 |
| 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
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
| Catheter Gauge | 22 French |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169561090 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061254
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 | 4 |
| Public Version Date | 2019-03-08 |
| Device Publish Date | 2017-06-05 |
On-Brand Devices [Select 3D™ II]
| 00643169696273 | CANNULA CB78522 SELECT 3DII 22FR |
| 00643169696266 | CANNULA CB78422 SELECT 3DII 22FR |
| 00643169561090 | CANN CB78422 SELECT 3D II 22FR 17L |
Trademark Results [Select 3D]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SELECT 3D 75606299 2656807 Live/Registered |
Medtronic, Inc. 1998-12-16 |
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