Duns Number:079962037
Device Description: The exhalation port is intended to be part of a single limb breathing circuit from the NKV 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.
Catalog Number
EXH3301P
Brand Name
Nihon Kohden
Version/Model Number
EXH3301P
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
Product Code
MNT
Product Code Name
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Public Device Record Key
3fb63df9-bc72-429e-8f2b-14feec05114d
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
October 11, 2022
Package DI Number
10843685100132
Quantity per Package
30
Contains DI Package
00843685100135
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 |