LUX-Dx™ Clinic Assistant app 622935-100
GUDID 00802526607615
LUX-Dx Clinic Assistant app (Mobile application)
BOSTON SCIENTIFIC CORPORATION
Implantable cardiac device management application software| Primary Device ID | 00802526607615 |
| NIH Device Record Key | 162aff39-db50-420d-a0e9-3b610f57c882 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUX-Dx™ Clinic Assistant app |
| Version Model Number | 622935-100 |
| Catalog Number | 622935-100 |
| Company DUNS | 106295384 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00802526607615 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193473
FDA Product Code
| MXD | Recorder, event, implantable cardiac, (with arrhythmia detection) |
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 | 2020-07-09 |
| Device Publish Date | 2020-07-01 |
Devices Manufactured by BOSTON SCIENTIFIC CORPORATION
| 08714729838005 - Capio SLIM | 2024-11-13 Suture Capturing Device |
| 00191506043193 - FARAWAVE™ NAV | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043209 - FARAWAVE™ NAV | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043216 - FARAWAVE™ | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043223 - FARAWAVE™ | 2024-10-30 Pulsed Field Ablation Catheter |
| 00191506043698 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
| 00191506043704 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
| 00191506043711 - FARASTAR™ | 2024-10-30 Pulsed Field Ablation Generator |
Trademark Results [LUX-Dx]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LUX-DX 87569443 not registered Dead/Abandoned |
Cardiac Pacemakers, Inc. 2017-08-15 |
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