Duns Number:689908411
Device Description: This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia This device is indicated for use to treatment of infants diagnosed with hyperbilirubinemia, commonly known as neonatal jaundice, which can cause a yellow discoloration of the skin and the whites of the eyes. The devices can be used in a hospital or at home.The device is designed to use for patient population described in the infant, who is age up to 3 months and weight less than 10 kg.
Catalog Number
-
Brand Name
Infant Phototherapy Equipment
Version/Model Number
BT-450
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K210289,K210289
Product Code
LBI
Product Code Name
Unit, Neonatal Phototherapy
Public Device Record Key
5c061a3d-c56a-495a-a570-7f71f560b533
Public Version Date
June 16, 2021
Public Version Number
1
DI Record Publish Date
June 08, 2021
Package DI Number
18800012345002
Quantity per Package
8
Contains DI Package
08800012345005
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |