Duns Number:079962037
Device Description: The NPPV cap-ONE Mask Set (Small) is used with the TG-980P CO2 sensor kit. The Mask Set co 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.
Catalog Number
MSK3315P
Brand Name
Nihon Kohden
Version/Model Number
MSK3315P
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K213521,K213521,K213521
Product Code
MNT
Product Code Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Public Device Record Key
b19e02dc-1317-4eb7-8a37-80b28e319e89
Public Version Date
October 19, 2022
Public Version Number
1
DI Record Publish Date
October 11, 2022
Package DI Number
20843685100078
Quantity per Package
4
Contains DI Package
00843685100074
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |