HVAD™ Controller
GUDID 00763000989514
CONTROLLER MCS1421CN WW
Heartware Inc.
Implantable ventricular circulatory assist system| Primary Device ID | 00763000989514 |
| NIH Device Record Key | 00f163be-e96e-4f5e-921b-e62bb8d532c2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HVAD™ Controller |
| Version Model Number | MCS1421CN |
| Company DUNS | 146054536 |
| Company Name | Heartware 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000989514 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P100047
FDA Product Code
| DSQ | Ventricular (assist) bypass |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2025-08-30 |
Devices Manufactured by Heartware Inc.
| 00763000989514 - HVAD™ Controller | 2025-09-08CONTROLLER MCS1421CN WW |
| 00763000989514 - HVAD™ Controller | 2025-09-08 CONTROLLER MCS1421CN WW |
| 00763000629717 - HeartWare® Battery | 2023-05-29 |
| 00888707007641 - HVAD® Pump Outflow Graft | 2023-04-20 |
| 00888707007658 - HVAD® Controller | 2023-04-20 |
| 00888707008020 - Alarm Adapter | 2023-04-20 |
| 00888707008037 - Patient Pack | 2023-04-20 |
| 00888707008044 - USB Flash Drive | 2023-04-20 |
| 00888707008051 - Data Cable | 2023-04-20 |
Trademark Results [HVAD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HVAD 85758552 not registered Dead/Abandoned |
HeartWare Inc. 2012-10-19 |
 HVAD 78910214 3730135 Live/Registered |
HeartWare, Inc. 2006-06-16 |
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