Duns Number:122612547
Device Description: Braun, Nasal Aspriator
Catalog Number
-
Brand Name
Braun
Version/Model Number
BNA100SP
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
KMA
Product Code Name
Irrigator, Powered Nasal
Public Device Record Key
bfeed614-c555-4acc-ac84-98173ff26c43
Public Version Date
October 07, 2020
Public Version Number
1
DI Record Publish Date
September 29, 2020
Package DI Number
10328785006169
Quantity per Package
6
Contains DI Package
00328785006162
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASES
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 97 |
2 | A medical device with a moderate to high risk that requires special controls. | 22 |