Duns Number:757258843
Device Description: BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radi BIS Extra Cellular Fluid Analysis. It is designed to provide real-time, noninvasive, radiation-free, multi-frequency measurement by applying and detecting a low-voltage electrical signal through the skin, via an electrode, and displaying the results on a monitor.New-Device
Catalog Number
222-LDEXU400
Brand Name
L-Dex® U400
Version/Model Number
U400
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K130338,K130338,K130338
Product Code
OBH
Product Code Name
Monitor, Extracellular Fluid, Lymphedema, Extremity
Public Device Record Key
1ffab1e6-d760-48ab-8a36-8eef35c56ee9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
B277222LDEXU4002
Quantity per Package
1
Contains DI Package
B277222LDEXU4001
Package Discontinue Date
-
Package Status
-
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |