Duns Number:689908411
Device Description: BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470n BT-400 Neonatal phototherapy is designed to emit the blue light wave length range 450-470nm spectrum to treat Neonatal Jaundice to use in Bassinets, Incubators, Open beds or Radiant warmer and consists of Head (Light Source), Control box with LCD window, Roll Stand (optional)
Catalog Number
MKT-400-1510
Brand Name
N/A
Version/Model Number
BT-400
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
K142332,K142332,K142332
Product Code
LBI
Product Code Name
Unit, Neonatal Phototherapy
Public Device Record Key
e2fe443a-f128-4288-a79d-fa0fc734b1e6
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
June 03, 2016
Package DI Number
10887529000110
Quantity per Package
1
Contains DI Package
00887529000113
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 |