Duns Number:787026855
Device Description: Relieves nasal congestionDesigned to reduce the spreading of germsThree different sized no Relieves nasal congestionDesigned to reduce the spreading of germsThree different sized nose tips and storage case
Catalog Number
-
Brand Name
ClearNose Nasal Aspirator
Version/Model Number
10681
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
-
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
KYZ
Product Code Name
Syringe, Irrigating (Non Dental)
Public Device Record Key
721b2f07-78b2-4e16-9f2f-6cb077876a5d
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 12, 2019
Package DI Number
10735282106818
Quantity per Package
18
Contains DI Package
00735282106811
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |