Duns Number:314101143
Device Description: Avalon FM30 Fetal Monitor for all external and internal Fetal Monitoring Applications incl Avalon FM30 Fetal Monitor for all external and internal Fetal Monitoring Applications including: 1US Transducer and 1 Toco Transducer, MECG Adapter Cable and DECG Reusable Legplate Adapter Cable and the capability of measuring DECG, MECG and IUP
Catalog Number
862199
Brand Name
PHILIPS Avalon FM30 Fetal Monitor
Version/Model Number
Avalon FM30 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
c8c0bf3c-e7bd-4fd6-a3aa-cd353fa08eb8
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 |