Primary Device ID | 08714729841739 |
NIH Device Record Key | c6b58d2d-5cdb-4d59-976c-8e171a09708e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rhythmia™ Mapping System |
Version Model Number | M004RA5200US0 |
Company DUNS | 021717889 |
Company Name | BOSTON SCIENTIFIC CORPORATION |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08714729841739 [Primary] |
DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2024-06-06 |
Device Publish Date | 2016-09-24 |
08714729841906 | Rhythmia Power Supply |
08714729880318 | Magnetic Tracking System Kit |
08714729842101 | Sensor Interface Unit (SIU) |
08714729842095 | System Control Unit (SCU) |
08714729842088 | Localization Generator |
08714729841739 | ECG Cable - Chest - US AAMI |
08714729841715 | ECG Cable - Limbs - US AAMI |
08714729841692 | ECG Cable - Trunk - US AAMI |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
RHYTHMIA 85800088 4790969 Live/Registered |
Boston Scientific Scimed, Inc. 2012-12-11 |