Duns Number:431208297
Device Description: Nasal Wash. Nose drug administration device intended specifically to administer medicinal Nasal Wash. Nose drug administration device intended specifically to administer medicinal substances or saline solutions to treat nose
Catalog Number
DR12P00
Brand Name
FLAEM Rhino Clear Sprint
Version/Model Number
P0709EM
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JPW
Product Code Name
Pump, Nebulizer, Electrically Powered
Public Device Record Key
01635ed0-2d36-4ea4-8a03-0dd03e982475
Public Version Date
March 10, 2022
Public Version Number
2
DI Record Publish Date
July 10, 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 | 1 |