Duns Number:118492643
Device Description: 1ea - sterile, pre-lubricated nasopharyngeal airway
Catalog Number
11-128
Brand Name
Nasal Trumpet
Version/Model Number
02
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 07, 2029
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
b45f6a8f-01b4-43ef-a533-0f14ed488265
Public Version Date
August 19, 2022
Public Version Number
3
DI Record Publish Date
April 03, 2020
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 |