Nihon Kohden MSK3315P
GUDID 20843685100078
The NPPV cap-ONE Mask Set (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.
NIHON KOHDEN ORANGEMED, INC.
CPAP/BPAP face mask, single-use| Primary Device ID | 20843685100078 |
| NIH Device Record Key | b19e02dc-1317-4eb7-8a37-80b28e319e89 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nihon Kohden |
| Version Model Number | MSK3315P |
| Catalog Number | MSK3315P |
| Company DUNS | 079962037 |
| Company Name | NIHON KOHDEN ORANGEMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com | |
| Phone | 949-502-6448 |
| techservice@orange-med.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 65 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00843685100074 [Primary] |
| GS1 | 10843685100071 [Package] Contains: 00843685100074 Package: Case [40 Units] In Commercial Distribution |
| GS1 | 20843685100078 [Package] Contains: 00843685100074 Package: Case [4 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213521
FDA Product Code
| MNT | Ventilator, Continuous, Minimal Ventilatory Support, Facility Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-19 |
| Device Publish Date | 2022-10-11 |
On-Brand Devices [Nihon Kohden ]
| 00843685100012 | The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to meet the gas deliv |
| 00843685100029 | The Nihon Kohden NKV-550-N is a continuous use ventilator that is designed to meet the gas deliv |
| 00843685100005 | The Nihon Kohden NKV-550-S is a continuous use ventilator that is designed to meet the gas deliv |
| 00843685100036 | The Nihon Kohden Graphic User Interface is a display that is used with all NKV-550 Ventilator co |
| 00843685100043 | The Nihon Kohden NKV-330 Ventilator is an assist ventilator intended to support adult and pediat |
| 10843685100170 | The NPPV cap-ONE Mask Set (Extra Small) is used with the TG-980P CO2 sensor kit. The Mask Set co |
| 00843685100135 | The exhalation port is intended to be part of a single limb breathing circuit from the NKV-330 v |
| 20843685100078 | The NPPV cap-ONE Mask Set (Small) is used with the TG-980P CO2 sensor kit. The Mask Set covers t |
| 10843685100064 | The NPPV cap-ONE Mask Set (Medium) is used with the TG-980P CO2 sensor kit. The Mask Set covers |
| 10843685100057 | The NPPV cap-ONE Mask Set (Large) is used with the TG-980P CO2 sensor kit. The Mask Set covers t |
| 00843685100166 | Nihon Kohden NKV-440 Ventilator System with SpO2/CO2 |
| 00843685100159 | Nihon Kohden NKV-440 Ventilator System |
Trademark Results [Nihon Kohden]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NIHON KOHDEN 78694136 3153499 Live/Registered |
NIHON KOHDEN CORPORATION 2005-08-17 |
 NIHON KOHDEN 73325128 1351521 Dead/Cancelled |
NIHON KOHDEN CORPORATION 1981-08-24 |
 NIHON KOHDEN 73139565 1130758 Dead/Cancelled |
NIHON KOHDEN KOGYO CO., LTD. 1977-08-31 |
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