Duns Number:809524291
Device Description: BoogieBaby nasal aspirator – flair tip
Catalog Number
-
Brand Name
BoogieBaby nasal aspirator – flair tip
Version/Model Number
VPBB15015100
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"
Yes
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
BYY
Product Code Name
Tube, Aspirating, Flexible, Connecting
Public Device Record Key
3886e713-15bd-4a50-a9ad-8b9355a955e0
Public Version Date
August 05, 2021
Public Version Number
1
DI Record Publish Date
July 28, 2021
Package DI Number
10814247020731
Quantity per Package
100
Contains DI Package
00814247020734
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 12 |
2 | A medical device with a moderate to high risk that requires special controls. | 36 |