Duns Number:008124539
Device Description: Oral Airways, Individually Bagged, Disposable, X-Large, 110 mm, Orange
Catalog Number
-
Brand Name
Oral Airways, Disposable
Version/Model Number
4767
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
ebb1f1b6-eba6-4571-bea6-2cb20bdc11b1
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
Package DI Number
00616784476728
Quantity per Package
24
Contains DI Package
00616784476711
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 |