AccessGUDID - DEVICE: EmbraceTM Electrodes Array (L) (07290016406030)

GUDID

Device Identifier (DI) Information

Brand Name: EmbraceTM Electrodes Array (L)
Version or Model: FG0003(X)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FG0003(X)
Company Name: O.B - TOOLS LTD

Primary DI Number: 07290016406030
Issuing Agency: GS1
Commercial Distribution End Date: January 14, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 534149604 *Terms of Use

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

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OSP	Uterine Electromyographic Monitor
HGM	System, Monitoring, Perinatal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep in cool dry place

Clinically Relevant Size

[?]

Size Type Text
Width: 280 Millimeter
Length: 320 Millimeter

Device Record Status

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

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
17290016406037	10	07290016406030	2020-01-14	Not in Commercial Distribution	Pack of 10 Embrace e
27290016406034	100	17290016406037	2020-01-14	Not in Commercial Distribution	10 packs of 10 arra