Duns Number:534149604
Device Description: Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydroge Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
Catalog Number
FG0003(X)
Brand Name
EmbraceTM Electrodes Array (L)
Version/Model Number
FG0003(X)
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 14, 2020
Issuing Agency
In GS1
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"
Yes
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
85fe8e45-dc46-42bf-af31-9fd78dbca6ba
Public Version Date
January 15, 2020
Public Version Number
3
DI Record Publish Date
February 12, 2017
Package DI Number
17290016406037
Quantity per Package
10
Contains DI Package
07290016406030
Package Discontinue Date
January 14, 2020
Package Status
Not in Commercial Distribution
Package Type
Pack of 10 Embrace e
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |