Duns Number:008124539
Device Description: Emergency Oral Airways KitInfant 40 mm, Child 60 mm, Small Adult 80 mm, Medium Adult 90 mm Emergency Oral Airways KitInfant 40 mm, Child 60 mm, Small Adult 80 mm, Medium Adult 90 mm, Large Adult 100 mm, XL Adult 110 mm
Catalog Number
-
Brand Name
Emergency Oral Airways Kit
Version/Model Number
4791
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
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
5932836e-aaad-4a47-b36a-a1cf017efb6e
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
Package DI Number
00616784479125
Quantity per Package
6
Contains DI Package
00616784479118
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |