Duns Number:008124539
Device Description: Oral Airway, Individually Bagged, Disposable, Infant, 40 mm, Pink
Catalog Number
-
Brand Name
Oral Airways, Disposable
Version/Model Number
4717
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
0c538aa3-517c-484b-91cd-7a016f9b6232
Public Version Date
November 17, 2020
Public Version Number
1
DI Record Publish Date
November 09, 2020
Package DI Number
00616784471723
Quantity per Package
24
Contains DI Package
00616784471716
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 |