Home GUDID 10843685100170 Nihon Kohden
Primary DI 10843685100170
Brand Nihon Kohden
Company NIHON KOHDEN ORANGEMED, INC.
Model MSK3316P
Catalog number MSK3316P
Device description The NPPV cap-ONE Mask Set (Extra Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers the patient nose and mouth and connects to the breathing circuit of the ventilator to monitor expiratory CO2 partial pressure and provide gas from the ventilator to the patient.
Published 2022-10-11
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MNT Sv70 Ventilator Anesthesiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10843685100170 Package GS1 40 In Commercial Distribution 20843685100177 Package GS1 4 In Commercial Distribution 00843685100173 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 10843685100170 10843685100170 20843685100177 20843685100177 00843685100173 00843685100173 843685100173 0843685100173
GMDN Terms# Term, Definition table Term Definition CPAP/BPAP face mask, single-use A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Atmospheric Pressure 70 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 95 Percent (%) Relative Humidity Storage Environment Temperature -20 Degrees Celsius 65 Degrees Celsius
Regulatory Flags# DUNS number 079962037 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true 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 09420012465511 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2025-08-13 09420012480866 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2025-08-13 08401934313389 ResScan RESMED CORP. MNT 2023-02-24 08401934313396 ResScan RESMED CORP. MNT 2023-02-24 09420012455000 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012455062 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012455338 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012455727 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012459695 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460295 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460615 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460639 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460738 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460752 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460776 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 09420012460790 Fisher & Paykel Healthcare FISHER & PAYKEL HEALTHCARE LIMITED MNT 2022-08-02 00606959048720 A Series, Sys One, Heater Hum Respironics, Inc. MNT 2020-10-16 00606959049024 DreamMapper Web (DM) Respironics, Inc. MNT 2020-10-16 00606959049031 DreamMapper Web (EMEA) Respironics, Inc. MNT 2020-10-16 00606959049062 DreamMapper Mobile App Android (EMEA) Respironics, Inc. MNT 2020-10-16 00606959049079 DreamMapper Mobile App Android (APAC) Respironics, Inc. MNT 2020-10-16 00606959049093 DreamMapper App iOS (EMEA) Respironics, Inc. MNT 2020-10-16 00606959051362 DreamMapper iOS China Instance Respironics, Inc. MNT 2020-10-16 00606959049109 DreamMapper App iOS (APAC) Respironics, Inc. MNT 2020-10-07 00606959044203 Care Orchestrator Respironics, Inc. MNT 2020-09-23 00606959052093 DreamMapper Web (DM) Respironics, Inc. MNT 2020-05-20 00606959053045 DreamMapper Web (DM) Respironics, Inc. MNT 2020-05-20 00606959054844 DreamMapper Web (DM) Respironics, Inc. MNT 2020-05-20 00606959058552 EncoreAnywhere Respironics, Inc. MNT 2019-12-29 00606959058569 EncoreAnywhere Respironics, Inc. MNT 2019-12-29
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