Primary Device ID | 05415067030108 |
NIH Device Record Key | a9945400-5c2f-43f6-badb-77203227a2a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AptiVue™ |
Version Model Number | 1014661 |
Catalog Number | 1014661 |
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 | false |
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 |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067030108 [Primary] |
IYO | System, imaging, pulsed echo, ultrasonic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-05-08 |
Device Publish Date | 2019-04-30 |
05415067049414 - Entrant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
05415067049421 - Gallant™ | 2024-05-03 VR Implantable Cardioverter Defibrillator |
05415067049469 - Entrant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
05415067049476 - Gallant™ | 2024-05-03 DR Implantable Cardioverter Defibrillator |
05415067049513 - Entrant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
05415067049520 - Gallant™ | 2024-05-03 HF Cardiac Resynchronization Therapy Defibrillator |
05415067047700 - TriClip™ | 2024-04-22 G4 Delivery System |
05415067047724 - TriClip™ | 2024-04-22 G4 Delivery System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
APTIVUE 87818494 not registered Live/Pending |
St. Jude Medical, LLC 2018-03-02 |