Duns Number:879057065
Catalog Number
-
Brand Name
BlowYo
Version/Model Number
BlowYo Water Based 3.4 fl oz
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K051295,K051295
Product Code
NUC
Product Code Name
Lubricant, Personal
Public Device Record Key
2a43c4fd-ee84-4024-9b8c-1352305e024c
Public Version Date
August 07, 2020
Public Version Number
4
DI Record Publish Date
March 15, 2018
Package DI Number
45060020002661
Quantity per Package
24
Contains DI Package
05060020002663
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 56 |