Duns Number:020091217
Device Description: The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MERIDIAN M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals.
Catalog Number
-
Brand Name
Meridian M110 Fetal Monitoring System
Version/Model Number
M110
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
6fafefae-b3b4-492d-915a-da7177abc697
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 06, 2017
Package DI Number
00867696000314
Quantity per Package
1
Contains DI Package
00867696000307
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Mixed case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |