Duns Number:314101143
Device Description: Avalon FM50 Fetal Monitor for all external and internal Fetal Monitoring Applications
Catalog Number
865071
Brand Name
PHILIPS Avalon FM50 Fetal Monitor
Version/Model Number
Avalon FM50 Fetal Monitor
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
HGM
Product Code Name
SYSTEM, MONITORING, PERINATAL
Public Device Record Key
c125beeb-1b26-43d5-a4ed-0d403921f906
Public Version Date
July 25, 2022
Public Version Number
6
DI Record Publish Date
October 03, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 209 |