FDA.reportPublic FDA data

Nihon Kohden

Primary DI
00843685100043
Brand
Nihon Kohden
Company
NIHON KOHDEN ORANGEMED, INC.
Model
NKV-330
Catalog number
NKV-330
Device description
The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support adult and pediatric patients who are breathing spontaneously and require a tidal volume of 100mL or more with an oxygen concentration of 21 to 100%. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications.
Published
2022-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
00843685100043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843685100043008436851000438436851000430843685100043

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Altitude: between -1250 and 9878 feet above sea level
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius65 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
Serial number
true
Manufacturing 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
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

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