Meridian Disposable fECG Electrode Patch

GUDID 00867696000345

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.

MINDCHILD MEDICAL

Electrocardiographic electrode, single-use

• Primary Device ID: 00867696000345
• NIH Device Record Key: e2ee1fd5-1228-4b48-a3c7-f8379bf80882
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Meridian Disposable fECG Electrode Patch
• Version Model Number: MDPA1
• Company DUNS: 020091217
• Company Name: MINDCHILD MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867696000321 [Primary]
GS1	00867696000338 [Package]; Contains: 00867696000321; Package: Case [20 Units]; In Commercial Distribution
GS1	00867696000345 [Package]; Contains: 00867696000338; Package: Case [5 Units]; In Commercial Distribution

FDA Product Code

• HGM: System, Monitoring, Perinatal

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: 2017-06-06

Devices Manufactured by MINDCHILD MEDICAL

• 00867696000314 - Meridian M110 Fetal Monitoring System: 2018-03-29 The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate
• 00867696000345 - Meridian Disposable fECG Electrode Patch: 2018-03-29The 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.
• 00867696000345 - Meridian Disposable fECG Electrode Patch: 2018-03-29 The MERIDIAN Disposable Electrode Patch consists of four patches, two for the mother’s abdomen and one for each of her sides,
• 00867696000352 - Meridian Cable Set: 2018-03-29