EmbraceTM Electrodes Array (L)

Basic Information

• Brand Name: EmbraceTM Electrodes Array (L)
• Primary DI: 07290016406030
• Version / Model: FG0003(X)
• Catalog Number: FG0003(X)
• Company Name: O.B - TOOLS LTD
• Labeler DUNS: 534149604
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 3
• Public Version Date: 2020-01-15
• Public Version Status: Update
• Public Device Record Key: 85fe8e45-dc46-42bf-af31-9fd78dbca6ba
• Distribution End Date: 2020-01-14

Device Description

Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OSP	Uterine Electromyographic Monitor	Obstetrics/Gynecology	884.2720	2
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	884.2740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38479	Cardiotocography telemetric monitoring system	An assembly of devices intended to be used to continuously measure and wirelessly transmit foetal heart rate and uterine contraction signals from a patient to a cardiotocograph/monitor. It typically consists of wireless patient worn transducers/electrodes (e.g., leads and electrodes or Doppler ultrasound transducer plus pressure transducer) with appropriate transmitting capability and a receiver unit; the cardiotocograph/monitor is not included. The system is typically used for ambulatory patients who require continuous monitoring before delivery.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016406030	GS1
Package	17290016406037	GS1	Pack of 10 Embrace e	10	Not in Commercial Distribution	2020-01-14
Package	27290016406034	GS1	10 packs of 10 arra	100	Not in Commercial Distribution	2020-01-14

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	280	Millimeter
Length	320	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep in cool dry place