Primary Device ID | B146EP010 |
NIH Device Record Key | 71a96eb2-0878-48ba-9f9a-e645dd0b8fff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ePatch |
Version Model Number | 900-0630-00 |
Company DUNS | 049529118 |
Company Name | BRAEMAR MANUFACTURING, LLC |
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 | false |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B146EP010 [Primary] |
DSH | Recorder, Magnetic Tape, Medical |
DSI | Detector And Alarm, Arrhythmia |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2018-12-12 |
B146EP020 | ePatch Holter Device |
B146EP010 | ePatch Holter Device |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EPATCH 88112022 not registered Live/Pending |
Braemar Manufacturing, LLC 2018-09-11 |
EPATCH 88097728 not registered Live/Pending |
Braemar Manufacturing, LLC 2018-08-29 |
EPATCH 88076150 not registered Live/Pending |
Multitech Medical Devices USA, LLC 2018-08-13 |
EPATCH 86899540 not registered Dead/Abandoned |
Cardio Designs and Marketing LLC 2016-02-05 |
EPATCH 86226958 4769807 Live/Registered |
Ergon Asphalt & Emulsions, Inc. 2014-03-20 |
EPATCH 86218793 not registered Dead/Abandoned |
Clinetik, LLC 2014-03-12 |
EPATCH 79002713 3100896 Dead/Cancelled |
James Shen 2003-11-27 |