Home GUDID 90884521725467 Zephyr
Primary DI 90884521725467
Brand Zephyr
Company ZEPHYR TECHNOLOGY LLC
Model BH3-M2
Catalog number BH3-M2
Device description BioModule
Published 2018-01-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 90884521725467 Package GS1 999 Not in Commercial Distribution 10884521725461 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 90884521725467 90884521725467 10884521725461 10884521725461
GMDN Terms# Term, Definition table Term Definition Electrocardiograph, professional, single-channel A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from only one configuration of electrodes (ECG-leads) at a time (single-channel). It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or data telemetry features might also be included.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 12 KiloPascal 107 KiloPascal Handling Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Handling Environment Temperature -4 Degrees Fahrenheit 113 Degrees Fahrenheit Special Storage Condition, Specify 0 0 Keep dry Special Storage Condition, Specify 0 0 Keep dry; Storage Environment Atmospheric Pressure 12 KiloPascal 107 KiloPascal Storage Environment Humidity 15 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -4 Degrees Fahrenheit 113 Degrees Fahrenheit
Regulatory Flags# DUNS number 796678527 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00884838119017 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119024 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119031 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119048 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119055 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119062 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119185 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119192 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119208 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119215 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00884838119222 Telemetry Accessories Philips Medizin Systeme Böblingen GmbH MHX 2026-05-28 00840682144292 CARESCAPE Ge Medical Systems Information Technologies, Inc. MHX 2025-06-04 B510PMMAX13 ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. MHX 2024-12-19 B510PMMAX15 ADVANCED PATIENT MONITOR ADVANCED INSTRUMENTATIONS, INC. MHX 2024-12-19 B353UB25501 UbiqVue Multiparameter Lifesignals, Inc. MHX 2024-11-29 10841522117688 XHIBIT SPACELABS HEALTHCARE (WASHINGTON), INC MHX 2024-06-07 B353UA2550BG1 UbiqVue Lifesignals, Inc. MHX 2024-05-15 B353UA2550C1 UbiqVue Lifesignals, Inc. MHX 2024-05-15 B353UA2550MR1 UbiqVue Lifesignals, Inc. MHX 2024-05-15 B353UA2550RB1 UbiqVue Lifesignals, Inc. MHX 2024-05-15 B353UA2550S1 UbiqVue Lifesignals, Inc. MHX 2024-05-15 B353UA2550R1 UbiqVue Lifesignals, Inc. MHX 2024-05-06 B353UB15501 UbiqVue Multiparameter Lifesignals, Inc. MHX 2024-05-06 00382830062947 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14 00382830062954 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14 00382830062961 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14 00382830062985 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14 00382830063005 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14 00382830063012 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14 00382830063029 Component Neuromonitoring System NATUS NEUROLOGY INCORPORATED MHX 2023-08-14