Duns Number:118492643
Device Description: 1ea - Robertazzi 28Fr Nasopharyngeal Airway, 1ea - Lubricating Jelly
Catalog Number
11-110
Brand Name
Nasal Trumpet
Version/Model Number
03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
September 28, 2023
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BTQ
Product Code Name
Airway, Nasopharyngeal
Public Device Record Key
b02cf219-bd44-4a09-94f3-5ec2eacca4f2
Public Version Date
April 12, 2022
Public Version Number
4
DI Record Publish Date
December 19, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 217 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |