Duns Number:367919120
Device Description: Pediatric Oral/Nasal CO2 Sampling with O2 Delivery Cannula for CapnoFlex Module
Catalog Number
2013067-004
Brand Name
Vital Signs
Version/Model Number
2013067-004
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
33cdf8e1-0285-4c22-afdb-3ab3a913ad1e
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
September 21, 2016
Package DI Number
50885403253551
Quantity per Package
10
Contains DI Package
10885403253553
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |