Duns Number:830432451
Device Description: AirLife™ Nasal ETCO2 Cannula, Adult with 7' O2 tube and 7' CO2 tube with male luer c AirLife™ Nasal ETCO2 Cannula, Adult with 7' O2 tube and 7' CO2 tube with male luer connector
Catalog Number
2812M-25
Brand Name
AirLife
Version/Model Number
2812M-25
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
e6dadb75-62d3-4cba-a78b-f4addae2cf3d
Public Version Date
August 05, 2022
Public Version Number
8
DI Record Publish Date
September 01, 2016
Package DI Number
50885403244948
Quantity per Package
25
Contains DI Package
10885403244940
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 |