Home GUDID 00841983103438 NA
Primary DI 00841983103438
Brand NA
Company NIHON KOHDEN AMERICA, INC.
Model ZB-102AA
Catalog number ZB-102AA
Device description TELEMETRY UNIT 64 CHANNEL, for WEE-1000A
Published 2016-09-24
Public version status Update
Distribution status 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 OLV Standard polysomnograph with electroencephalograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OLV Standard Polysomnograph With Electroencephalograph Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841983103438 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 00841983103438 00841983103438 841983103438 0841983103438
GMDN Terms# Term, Definition table Term Definition Electrocardiography telemetric monitoring system receiver A mains electricity (AC-powered) component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).
Regulatory Flags# DUNS number 021063219 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label false 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 08720256698470 Onera STS 2 Onera B.V. OLV 2026-05-26 09342451002785 Compumedics Falcon COMPUMEDICS LIMITED OLV 2026-03-12 00840067104200 Cadwell CADWELL INDUSTRIES, INC. OLV 2026-03-01 15694311112075 Noxturnal Web Nox Medical ehf. OLV 2025-06-05 00850063034074 Sleep Profiler ADVANCED BRAIN MONITORING, INC. OLV 2024-08-27 00850015266805 X-Series, X8 ADVANCED BRAIN MONITORING, INC. OLV 2023-04-05 00850015266225 Sleep Profiler ADVANCED BRAIN MONITORING, INC. OLV 2022-08-25 10190752161122 LTV VYAIRE MEDICAL, INC. OLV 2021-03-12 10190752161993 SOMNOSTAR VYAIRE MEDICAL, INC. OLV 2021-03-12 10190752167629 Avea VYAIRE MEDICAL, INC. OLV 2021-03-12 10190752173545 LTV VYAIRE MEDICAL, INC. OLV 2021-03-12 09342451002112 Siesta COMPUMEDICS USA, INC. OLV 2020-12-16 09342451001788 Siesta COMPUMEDICS USA, INC. OLV 2020-12-15 00840067102824 Arc Essentia CADWELL INDUSTRIES, INC. OLV 2020-12-10 00840067102848 Sierra Summit CADWELL INDUSTRIES, INC. OLV 2020-12-10 00850015266201 Sleep Profiler PSG2 ADVANCED BRAIN MONITORING, INC. OLV 2020-09-30 00606959057067 Alice 6 Respironics, Inc. OLV 2020-02-26 00606959057074 Alice 6 Respironics, Inc. OLV 2020-02-26 B62536084000 OmniPro System Mays & Asscoiates OLV 2019-12-09 00850008393204 Neurovirtual NEUROVIRTUAL USA, INC. OLV 2019-11-26 00850008393228 Neurovirtual NEUROVIRTUAL USA, INC. OLV 2019-11-26 00850008393242 Neurovirtual NEUROVIRTUAL USA, INC. OLV 2019-11-26 00850008393259 Neurovirtual NEUROVIRTUAL USA, INC. OLV 2019-11-26 00817111021158 Serenity PZ01 Piezo Sensor, 1.5mm DIN, 3.0m NEUROTRONICS, INC. OLV 2019-05-01 00817111021165 Serenity PZ01 Piezo Sensor, 249 Keyhole, 3.0m NEUROTRONICS, INC. OLV 2019-05-01 08056446900949 BE Micro 21 CH MONO PLUG-IN HEADBOX EB NEURO SPA OLV 2019-04-02 00606959052055 Therapy Interface Tubing kit Respironics, Inc. OLV 2019-03-04 05060275450127 Trackit Sleepwalker LIFELINES LIMITED OLV 2019-01-18 05060275450134 Trackit Sleepwalker LIFELINES LIMITED OLV 2019-01-18 05060275450141 Trackit Sleepwalker LIFELINES LIMITED OLV 2019-01-18