Duns Number:078497467
Device Description: BF70 Bluetooth® Diagnostic Scale
Catalog Number
-
Brand Name
Beurer
Version/Model Number
BF70 (Art.-No. 747.70)
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PUH
Product Code Name
Analyzer, Body Composition, Exempt
Public Device Record Key
1c35a98e-f210-420c-8122-08eb71f7b8fb
Public Version Date
February 25, 2019
Public Version Number
4
DI Record Publish Date
May 08, 2017
Package DI Number
10853879007062
Quantity per Package
4
Contains DI Package
00853879007065
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |
U | Unclassified | 2 |