Home GUDID 00817980020443 Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder
Primary DI 00817980020443
Brand Vasomedical-Biox™ Model 1307 3 CH ULTRA Recorder
Company VASOMEDICAL, INC.
Model Model 1307 Kit
Catalog number A10-1307-00
Device description Model 1307 3 CH ULTRA Recorder
Published 2016-11-29
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true Product Codes# Code, Name table Code Name DSH RECORDER, MAGNETIC TAPE, MEDICAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DSH Recorder, Magnetic Tape, Medical Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00817980020443 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00817980020443 00817980020443 817980020443 0817980020443
GMDN Terms# Term, Definition table Term Definition Electrocardiographic ambulatory recorder An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 55 Degrees Celsius
Regulatory Flags# DUNS number 197210248 Device count 1 Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00817980020559 2GB SD Memory Card Model 1303 A10-0011 2016-11-29 00817980020566 3-Ch ECG Holter Patient Cable w/5 Leads Model 1303 A10-0052 2016-11-29 00817980020573 3-Ch ECG Holter Patient Cable w/7 Leads Model 1303 A10-0053 2016-11-29 00817980020580 12-Ch ECG Holter Patient Cable w/10 Leads Model 1304 A10-0054 2016-11-29 00817980020597 USB SD Card Reader Model 1303 A10-0015 2016-11-29 00817980020603 Infared Communication Adaptor Model 1805 A10-0022 2016-11-29 00817980020610 Portable Case w/Belt for 1303 Recorder Model 1303 A10-0041 2016-11-29 00817980020627 Portable case with Belt for 1304/1305 Recorder Model 1304 A10-0042 2016-11-29 00817980020634 Portable case with Belt for 1805 Monitor Model 1303 A10-0050 2016-11-29 00817980020641 Portable case with Belt for 2301/2302 Recorders Model 2301 A10-0043 2016-11-29 00817980020870 3 Lead Integrated ECG Cable (AngioNew® V & VI) Model AngioNew VI A12-0033 2016-11-29 00817980020887 3 Lead Integrated ECG Cable (Models MC2, TS4 and Lumenair™) Model Lumenair V10-0017 2016-11-29 00817980020894 3 Lead Integrated ECG Cable with adapter (Model TS3) Model TS3 V10-0021 2016-11-29 00817980020900 ECG Cable Adaptor-for use with V10-0017 (Model TS3) Model TS3 V83-0066 2016-11-29 00817980021198 Finger Plethysmograph (Models TS3 and TS4) Model TS-4 V83-0006 2016-11-29 00817980021204 Finger Plethysmograph (Model MC2, AngioNew® V& VI) Model AngioNew VI V23-0007 2016-11-29 00817980021402 Vasomedical™ EZ™ O2 A Adult Pulse Oximeter Model EZ A13-0002-03-01 2016-11-29 00817980021419 Vasomedical™ EZ™ O2 P Adult/Pediatric Pulse Oximeter Model EZ A13-0002-05-01 2016-11-29 00817980021426 Vasomedical™ EZ™ Pediatric Probe for EZ™ O2 P (children over 3 yrs & Sm.Adults) Model EZ A13-0070 2016-11-29 00817980021433 Vasomedical™ EZ™ O2 Wrist Pulse Oximeter Model EZ A13-0002-02-01 2016-11-29
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