Duns Number:108631797
Device Description: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia.
Catalog Number
-
Brand Name
Bilisoft 2.0
Version/Model Number
009765
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K053568
Product Code
LBI
Product Code Name
Unit, Neonatal Phototherapy
Public Device Record Key
c70a713a-ae94-466d-8770-1554185ec08f
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 14, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 120 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |