Duns Number:504406273
Catalog Number
-
Brand Name
NasoSafe Nasopharyngeal Airway ID Size 8.5mm 36 Fr
Version/Model Number
038-95-085U
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
BTQ
Product Code Name
Airway, Nasopharyngeal
Public Device Record Key
a8b352dd-6ab8-487d-b2a0-e6f2a08f5621
Public Version Date
February 27, 2020
Public Version Number
1
DI Record Publish Date
February 19, 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 | 715 |
2 | A medical device with a moderate to high risk that requires special controls. | 465 |