TOCO-MECG transducer

GUDID 06944413858671

Edan Instruments, Inc.

Foetal/maternal prenatal monitor

• Primary Device ID: 06944413858671
• NIH Device Record Key: d03c43c7-840e-4237-a2a7-7587297d5892
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TOCO-MECG transducer
• Version Model Number: TOCO-EA
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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	06944413858671 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241882

FDA Product Code

• DRT: Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

On-Brand Devices [TOCO-MECG transducer]

• 06944413858671: TOCO-EA
• 06944413858664: TOCO-EF