LUX-Dx™ Insertable Cardiac Monitor 60M301-101
GUDID 00802526607103
LUX-Dx Insertable Cardiac Monitor
BOSTON SCIENTIFIC CORPORATION
Implantable cardiac monitor| Primary Device ID | 00802526607103 |
| NIH Device Record Key | d424f4c6-1c56-440a-b773-4f18d6798912 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LUX-Dx™ Insertable Cardiac Monitor |
| Version Model Number | M301 |
| Catalog Number | 60M301-101 |
| Company DUNS | 106295384 |
| Company Name | BOSTON SCIENTIFIC CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00802526607103 [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 | true |
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
| 08714729424260 - Contour™ | 2024-09-11 Ureteral Stent Set |
| 08714729462583 - Contour™ | 2024-09-11 Ureteral Stent Set |
| 08714729462651 - Contour™ | 2024-09-11 Ureteral Stent Set |
| 08714729462798 - Contour™ | 2024-09-11 Ureteral Stent Set |
| 00191506020798 - RHYTHMIA HDx™ | 2024-09-11 Ablation Connection Box - IntellaNav StablePoint™ (for INTELLAGEN™) |
| 00191506020804 - RHYTHMIA HDx™ | 2024-09-11 Ablation Connection Box (for INTELLAGEN™) |
| 08714729010975 - Connector | 2024-09-09 FOR 7F THROUGH 10F CATHETERS WITH LUER LOCK FITTING Ureteral Catheter Connector |
| 08714729010982 - Connector | 2024-09-09 FOR 3F THROUGH 6F CATHETERS WITH LUER LOCK FITTING Ureteral Catheter Connector |
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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