MC2X™
GUDID 00763000193171
CANN CB91429C MC2X 29/29/29 FR
MEDTRONIC, INC.
Cardiopulmonary bypass cannula, venous| Primary Device ID | 00763000193171 |
| NIH Device Record Key | 346ce5b8-8d72-4237-992f-737ba4c03caf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MC2X™ |
| Version Model Number | CB91429C |
| 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 |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000193171 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-14 |
| Device Publish Date | 2019-03-06 |
On-Brand Devices [MC2X™]
| 00643169696990 | CANN CB91437C MC2X 29/46/37FR 17L |
| 00643169696983 | CANN CB91429C MC2X 29/29/29 FR |
| 00643169696976 | CANN CB91429 MC2X 29/29/29 FR |
| 00763000193171 | CANN CB91429C MC2X 29/29/29 FR |
| 00763000193164 | CANN CB91429 MC2X 29/29/29 FR |
Trademark Results [MC2X]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MC2X 78276546 2878018 Live/Registered |
Medtronic, Inc. 2003-07-21 |
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