Duns Number:830432451
Device Description: AirLife™ Nasal ETCO2 Cannula, Adult 7' O2 tube and U/Connect-It™ Adapter with AirLife™ Nasal ETCO2 Cannula, Adult 7' O2 tube and U/Connect-It™ Adapter with male luer connector
Catalog Number
2812M-10U
Brand Name
AirLife
Version/Model Number
2812M-10U
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
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
cd53a1f8-7687-48fb-b8bf-da7b4f1e6e5d
Public Version Date
August 05, 2022
Public Version Number
8
DI Record Publish Date
September 01, 2016
Package DI Number
50885403231221
Quantity per Package
10
Contains DI Package
10885403231223
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 876 |
| 3 | A medical device with high risk that requires premarket approval | 29 |