EmbraceTM Electrodes Array (L) FG0003(X)

GUDID 07290016406030

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

O.B - TOOLS LTD

Cardiotocography telemetric monitoring system

• Primary Device ID: 07290016406030
• NIH Device Record Key: 85fe8e45-dc46-42bf-af31-9fd78dbca6ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EmbraceTM Electrodes Array (L)
• Version Model Number: FG0003(X)
• Catalog Number: FG0003(X)
• Company DUNS: 534149604
• Company Name: O.B - TOOLS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +97246040162
• Email: info@ob-tools.com

Device Dimensions

• Width: 280 Millimeter
• Length: 320 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep in cool dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016406030 [Primary]
GS1	17290016406037 [Package]; Package: Pack of 10 Embrace e [10 Units]; In Commercial Distribution
GS1	27290016406037 [Package]; Contains: 17290016406037; Package: 10 packs of 10 arra [100 Units]; In Commercial Distribution

FDA Product Code

• OSP: Uterine Electromyographic Monitor

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-12

Devices Manufactured by O.B - TOOLS LTD

• 07290016406016 - TrueLabor Maternal Unit: 2018-03-29 TrueLabor's Maternal Unit is connected via a proprietary connector to the Embrace electrode array. The MU acquires EMG signals a
• 07290016406023 - TrueLabor Monitor Adapter: 2018-03-29 The TrueLabor's Monitor Adapter for the hospital maternal/fetal monitoring system. The corresponding Maternal Unit transmits the
• 07290016406030 - EmbraceTM Electrodes Array (L): 2018-03-29Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor Maternal Unit.
• 07290016406030 - EmbraceTM Electrodes Array (L): 2018-03-29 Proprietary bio-compatible patch electrode array with nine Ag/AgCl pads lined with hydrogel. Intended to be used with TrueLabor