Duns Number:079962037
Device Description: The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to meet the gas The Nihon Kohden NKV-550-U is a continuous use ventilator that is designed to meet the gas delivery and performance requirements for neonatal through adult patients. The NKV-550 Series Ventilator System is intended to provide continuous ventilation using medical oxygen and external sources of compressed medical air to deliver oxygen concentrations of 21% to 100%. The ventilator design is comprised of two major components, the Breath Delivery Unit (BDU) and the Graphic User Interface (GUI).
Catalog Number
NKV-550-U
Brand Name
Nihon Kohden
Version/Model Number
NKV-550-U
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2029
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
-
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
K181695
Product Code
CBK
Product Code Name
Ventilator, Continuous, Facility Use
Public Device Record Key
e26498dc-74f2-4532-8e77-f886919fc279
Public Version Date
March 30, 2020
Public Version Number
2
DI Record Publish Date
May 02, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |