MYOtherm XP™
GUDID 20763000219080
TRILLIUM MYOTHERM XP41T
MEDTRONIC, INC.
Cardioplegia solution administration kit| Primary Device ID | 20763000219080 |
| NIH Device Record Key | 2f4586d2-6802-40e3-9fdc-6c4ded0c9ed1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MYOtherm XP™ |
| Version Model Number | XP41T |
| 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
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store the product at room temperature. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000219086 [Primary] |
| GS1 | 20763000219080 [Package] Contains: 00763000219086 Package: PK [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162958
FDA Product Code
| DTN | Reservoir, blood, 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 | 2020-08-14 |
| Device Publish Date | 2020-08-06 |
On-Brand Devices [MYOtherm XP™]
| 20643169766932 | HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK |
| 20643169766918 | HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK |
| 20763000218991 | HEAT EXCHANGER CBXP41B MYOTHERM INC 4PK |
| 20763000218953 | HEAT EXCHANGER CBXP41 MYOTHERM INC 4PK |
| 20763000219080 | TRILLIUM MYOTHERM XP41T |
| 20763000218342 | CARDIOPLEGIA XP41BT MYOTHERM XP4 1BT 4PK |
Trademark Results [MYOtherm XP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYOTHERM XP 75390353 2289454 Live/Registered |
MEDTRONIC INTERNATIONAL TRADING, INC. 1997-11-14 |
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