Duns Number:757258843
Device Description: DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical ass DF50 Single Frequency Bioimpedance; A bioimpedance (BIA) device to aid in the clinical assessment of fluid status and body composition by a healthcare professional in healthy individuals.US New Device
Catalog Number
223-DF50
Brand Name
Imp DF50
Version/Model Number
DF50
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 13, 2017
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K050395,K050395,K050395
Product Code
MNW
Product Code Name
Analyzer, Body Composition
Public Device Record Key
54b9f6c5-3c07-4c71-9f3f-72acb1d52fb0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 13, 2017
Package DI Number
B277223DF502
Quantity per Package
1
Contains DI Package
B277223DF501
Package Discontinue Date
February 13, 2017
Package Status
Not in Commercial Distribution
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 |