MC2X®
GUDID 00643169560505
CANN CB91429 MC2X 29/29/29FR 17L
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, venous| Primary Device ID | 00643169560505 |
| NIH Device Record Key | ced87e0b-a39f-4b7f-b357-c5b0fd328984 |
| Commercial Distribution Discontinuation | 2017-08-25 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | MC2X® |
| Version Model Number | CB91429 |
| 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 | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 French |
| Catheter Gauge | 29 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 | 00643169560505 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140165
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 | 2016-10-10 |
On-Brand Devices [MC2X®]
| 00643169560512 | CANN CB91429C MC2X VEN 29/29/29FR 17L |
| 00643169560505 | CANN CB91429 MC2X 29/29/29FR 17L |
| 20643169490158 | CANNULA 91429C MC2X VEN 29FR 10PK 17L |
| 20643169463022 | CANNULA 91429 MC2X 29/29/29FR 10PK 17L |
| 00643169159280 | CANN CB91437C MC2X 29/46/37F17 |
| 00643169159273 | CANN CB91437 MC2X 29/46/37F 17 |
| 00643169159266 | CANN CB91429C MC2X VEN 29/29/29F |
| 00643169159259 | CANN CB91429 MC2X VEN 29/29/29FR |
| 20613994887058 | CANNULA 91437 MC2X 29/37FR 10PK 17L |
| 20613994887041 | CANNULA 91437C MC2X 29/37FR CON 10P 17L |
Trademark Results [MC2X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MC2X 78276546 2878018 Live/Registered |
Medtronic, Inc. 2003-07-21 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.