Duns Number:020091217
Device Description: The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abd The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides, which provides continuous fetal signal capture during fetal movement.
Catalog Number
-
Brand Name
Meridian Disposable fECG Electrode Patch
Version/Model Number
MDPA1
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
Yes
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
e2ee1fd5-1228-4b48-a3c7-f8379bf80882
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 06, 2017
Package DI Number
00867696000345
Quantity per Package
5
Contains DI Package
00867696000338
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |