Primary Device ID | 00851074007347 |
NIH Device Record Key | e61a0b41-2e2e-4431-9886-4a106f7fdc2c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | A.C.T. (American Cardiac Telemetry) |
Version Model Number | Sirona |
Catalog Number | RX93030-008 |
Company DUNS | 080555401 |
Company Name | DATRIX 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 | 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 | 760 480-8874 |
TBREWER@DATRIXMED.COM |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00851074007347 [Primary] |
MWJ | Electrocardiograph,Ambulatory(Without Analysis) |
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 | 2018-03-05 |
00851074007385 - CardioLabs | 2019-11-08 ECG Recorder (Event) |
00851074007392 - TLC Diagnostics | 2019-11-08 ECG recorder |
00851074007361 - Datrix | 2019-11-08 ECG Recorder |
00851074007002 - Sirona | 2019-11-08 ECG Recorder |
00851074007019 - VX3+ | 2019-11-08 Holter Recorder |
00851074007026 - VX3+ | 2019-11-08 Holter Recorder |
00851074007033 - BodyGuardian | 2019-11-08 Holter Recorder |
00851074007040 - CardioHolter | 2019-11-08 Holter Recorder |