Duns Number:008124539
Device Description: Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) Tubing, Female Luer Connector, Pediatric, Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) Tubing, Female Luer Connector, Pediatric, Standard O2 Tubing Connector
Catalog Number
-
Brand Name
Resp-O2 EtCO2 Nasal Sampling Cannula
Version/Model Number
33190
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"
-
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
b2215c51-c0bc-48e7-b2b8-b323ab9ffebd
Public Version Date
April 26, 2022
Public Version Number
1
DI Record Publish Date
April 18, 2022
Package DI Number
00840117318885
Quantity per Package
25
Contains DI Package
00840117318816
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |