Duns Number:548312355
Catalog Number
-
Brand Name
VCOMIN Fetal Doppler
Version/Model Number
FD-231D
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 24, 2020
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
K182526
Product Code
KNG
Product Code Name
Monitor, Ultrasonic, Fetal
Public Device Record Key
e5513e5b-1291-4dd3-82bf-e18e9a58de8c
Public Version Date
November 26, 2020
Public Version Number
2
DI Record Publish Date
July 15, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |