Duns Number:022721133
Device Description: ETCO2 Filtered Sampling Line with adult/pediatric 15 mm airway adapter. With Nafion moistu ETCO2 Filtered Sampling Line with adult/pediatric 15 mm airway adapter. With Nafion moisture reduction technology.
Catalog Number
4MSF3-L-13
Brand Name
N/A
Version/Model Number
4MSF5-L-13
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
-
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
K151421,K151421
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
b1db0bcc-d31a-4c68-8245-3d0f2c0dc25a
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
November 22, 2018
Package DI Number
10607411963008
Quantity per Package
25
Contains DI Package
00607411963001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |