FDA.reportPublic FDA data

Nihon Kohden

Primary DI
00843685100173
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNTVentilator, Continuous, Minimal Ventilatory Support, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNTSv70 VentilatorAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213521000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213521000Nihon Kohden NKV-330 Ventilator SystemNihon Kohden Orangemed, Inc.2022-07-01MNT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843685100170PackageGS140In Commercial Distribution
20843685100177PackageGS14In Commercial Distribution
00843685100173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084368510017010843685100170
2084368510017720843685100177
00843685100173008436851001738436851001730843685100173

GMDN Terms#

Term, Definition table
TermDefinition
CPAP/BPAP face mask, single-useA 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
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
949-502-6448techservice@orange-med.com

Regulatory Flags#

DUNS number
079962037
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843685100005Nihon KohdenNKV-550-SNKV-550-S2019-10-28
00843685100029Nihon KohdenNKV-550-NNKV-550-N2019-10-28
00843685100012Nihon KohdenNKV-550-UNKV-550-U2019-05-02
00843685100159Nihon KohdenNKV-4402023-06-05
00843685100166Nihon KohdenNKV-4402023-06-05
00843685100036Nihon KohdenDSP5500ADSP5500A2020-03-27
00843685100135Nihon KohdenEXH3301PEXH3301P2022-10-11
00843685100050Nihon Kohden MSK3313PMSK3313P2022-10-11
00843685100067Nihon Kohden MSK3314PMSK3314P2022-10-11
00843685100074Nihon Kohden MSK3315PMSK3315P2022-10-11
10843685100057Nihon Kohden MSK3313PMSK3313P2022-10-11
10843685100064Nihon Kohden MSK3314PMSK3314P2022-10-11
20843685100078Nihon Kohden MSK3315PMSK3315P2022-10-11
10843685100170Nihon Kohden MSK3316PMSK3316P2022-10-11
00843685100043Nihon KohdenNKV-330NKV-3302022-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09420012465511Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
09420012480866Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2025-08-13
08401934313389ResScanRESMED CORP.MNT2023-02-24
08401934313396ResScanRESMED CORP.MNT2023-02-24
09420012455000Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455062Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455338Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012455727Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012459695Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460295Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460615Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460639Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460738Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460752Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460776Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
09420012460790Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDMNT2022-08-02
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00606959049024DreamMapper Web (DM)Respironics, Inc.MNT2020-10-16
00606959049031DreamMapper Web (EMEA)Respironics, Inc.MNT2020-10-16
00606959049062DreamMapper Mobile App Android (EMEA)Respironics, Inc.MNT2020-10-16
00606959049079DreamMapper Mobile App Android (APAC)Respironics, Inc.MNT2020-10-16
00606959049093DreamMapper App iOS (EMEA)Respironics, Inc.MNT2020-10-16
00606959051362DreamMapper iOS China InstanceRespironics, Inc.MNT2020-10-16
00606959049109DreamMapper App iOS (APAC)Respironics, Inc.MNT2020-10-07
00606959044203Care OrchestratorRespironics, Inc.MNT2020-09-23
00606959052093DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959053045DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959054844DreamMapper Web (DM)Respironics, Inc.MNT2020-05-20
00606959058552EncoreAnywhereRespironics, Inc.MNT2019-12-29
00606959058569EncoreAnywhereRespironics, Inc.MNT2019-12-29