Duns Number:092673953
Device Description: 50` Neonatal Circuit, Temp port, Prox line, Drop line, Neo
Catalog Number
-
Brand Name
Ventilator Circuit, Neonatal, 50'
Version/Model Number
N6205CKT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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"
Yes
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
-
Product Code
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
33425deb-f500-436b-811e-a380f3b993ea
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
March 06, 2017
Package DI Number
10709078002943
Quantity per Package
30
Contains DI Package
00709078002946
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |