Duns Number:799295915
Device Description: Nasogel provides moisture to hydrate and lubricate dry and nasal passages caused by dry cl Nasogel provides moisture to hydrate and lubricate dry and nasal passages caused by dry climate and indoor heat. It helps reduce nasal dryness experienced during air travel, oxygen, sleep apnea equipment device as well as dryness symptoms caused by various medical conditions.
Catalog Number
GSP30-6R-96-ENU-USL
Brand Name
NeilMed Nasogel
Version/Model Number
Nasogel Spray
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCJ
Product Code Name
Applicator, Ent
Public Device Record Key
f787b90c-189e-4205-ae3f-4876a2adb6b8
Public Version Date
July 12, 2022
Public Version Number
1
DI Record Publish Date
July 04, 2022
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 | 3 |
| U | Unclassified | 1 |