FDA.reportPublic FDA data

Nihon Kohden

Primary DI
00843685100135
Brand
Nihon Kohden
Company
NIHON KOHDEN ORANGEMED, INC.
Model
EXH3301P
Catalog number
EXH3301P
Device description
The exhalation port is intended to be part of a single limb breathing circuit from the NKV-330 ventilator. The exhalation port provides a fixed leak and connection for pressure measurement.
Published
2022-10-11
Public version status
Update
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
10843685100132PackageGS130In Commercial Distribution
00843685100135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084368510013210843685100132
00843685100135008436851001358436851001350843685100135

GMDN Terms#

Term, Definition table
TermDefinition
Ventilator breathing circuit, single-useAn assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.

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 Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

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
00843685100050Nihon Kohden MSK3313PMSK3313P2022-10-11
00843685100067Nihon Kohden MSK3314PMSK3314P2022-10-11
00843685100074Nihon Kohden MSK3315PMSK3315P2022-10-11
00843685100173Nihon Kohden MSK3316PMSK3316P2022-10-11
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
00606959048720A Series, Sys One, Heater HumRespironics, Inc.MNT2020-10-16
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