Duns Number:507261522
Device Description: Airway Gas Sampling Products are intended for continuous monitoring of expired and inspire Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
Catalog Number
3090121002
Brand Name
GE Healthcare Airway Adapter
Version/Model Number
Adult/Pediatric
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
59af90d4-92be-4891-9d2f-b6ca08f7390b
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
February 20, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |