Duns Number:092673953
Device Description: Hauge ll Airway Conscious Sedation Kit with 7' Co2/O2 line with , male luer connectors, he Hauge ll Airway Conscious Sedation Kit with 7' Co2/O2 line with , male luer connectors, headstrap, tongue depressor, 2" pigtail with female luer
Catalog Number
-
Brand Name
Hauge ll Airway Conscious Sedation Kit
Version/Model Number
6595
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
CAE
Product Code Name
Airway, Oropharyngeal, Anesthesiology
Public Device Record Key
c40f8b97-7842-4ed8-863d-641eeaec57e6
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
10709078011570
Quantity per Package
20
Contains DI Package
00709078011573
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |