Fetal & maternal monitor

GUDID 06944413806849

Edan Instruments, Inc.

Foetal cardiac monitor

• Primary Device ID: 06944413806849
• NIH Device Record Key: 57a1bfa3-d3ce-465e-830b-031b8c3e8f7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fetal & maternal monitor
• Version Model Number: FM-9000
• 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	06944413806849 [Primary]

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: 2016-09-01

On-Brand Devices [Fetal & maternal monitor]

• 06944413806856: FM-9000 Plus
• 06944413806849: FM-9000
• 06944413806832: FM-6000
• 06944413800465: F6 Express
• 06944413800458: F6
• 06944413800441: F9 Express
• 06944413800434: F9