HeartMate 3™ ZMOD-10002222US
GUDID 05415067038418
Surgical Hand Tools
ST. JUDE MEDICAL, INC.
Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable Cardiothoracic surgical procedure kit, non-medicated, reusable| Primary Device ID | 05415067038418 |
| NIH Device Record Key | b4d037a7-2ca6-42ac-83da-8b973dd5b13b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartMate 3™ |
| Version Model Number | 10002222US |
| Catalog Number | ZMOD-10002222US |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024013259 [Previous] |
| GS1 | 05415067038418 [Primary] |
FDA Product Code
| DSQ | Ventricular (assist) bypass |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
[05415067038418]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-05 |
| Device Publish Date | 2022-09-27 |
On-Brand Devices [HeartMate 3™]
| 05415067041654 | Apical Cuff Holder |
| 05415067038418 | Surgical Hand Tools |
Trademark Results [HeartMate 3]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HEARTMATE 3 86722375 5464938 Live/Registered |
Thoratec Corporation 2015-08-12 |
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