Duns Number:002348191
Device Description: Color-Coded Guedel Airway 90 mm
Catalog Number
1159
Brand Name
HUDSON RCI
Version/Model Number
IPN029560
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
08abfdc2-221a-4dcd-83e8-a0ef84d8b890
Public Version Date
July 01, 2021
Public Version Number
2
DI Record Publish Date
May 08, 2019
Package DI Number
34026704656333
Quantity per Package
48
Contains DI Package
14026704656339
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |