Duns Number:618825723
Device Description: OXYGEN NASAL CANNULA CHILD 7FT TUBE, W/CO2 SAMPLING LINE (MALE LUER)
Catalog Number
587400
Brand Name
KENTRON CAPNOGRAPHY
Version/Model Number
587400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143150,K143150
Product Code
CCK
Product Code Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Public Device Record Key
243635b2-113d-4e2b-a57f-8144a9e9a839
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
00852244007396
Quantity per Package
50
Contains DI Package
10852244007393
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 155 |