Duns Number:002657679
Device Description: Bili-Bonnet Ultra-Preemie size phototherapy masks to protect infants eyes from phototherap Bili-Bonnet Ultra-Preemie size phototherapy masks to protect infants eyes from phototherapy for treatment of jaundice.
Catalog Number
01C
Brand Name
Bili-Bonnet
Version/Model Number
01C
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
Yes
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
-
Product Code
FOK
Product Code Name
Pad, Neonatal Eye
Public Device Record Key
43dd0e4d-97ed-4911-9ead-f66cfadbb3b2
Public Version Date
August 11, 2020
Public Version Number
1
DI Record Publish Date
August 03, 2020
Package DI Number
10815090010177
Quantity per Package
50
Contains DI Package
00815090010170
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX