Duns Number:113412019
Catalog Number
-
Brand Name
Fetal Monitor Remote Display
Version/Model Number
27" Wall Mount
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K931133
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
7e7501b8-963c-4286-b5e3-b0dadd89f8ad
Public Version Date
May 19, 2020
Public Version Number
2
DI Record Publish Date
September 27, 2019
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 |