LifeDop® 150A Professional with 3.0 MHz Fetal Probe

GUDID 00888937019872

LifeDop® 150A Professional with 3.0 MHz Fetal Probe

Coopersurgical, Inc.

Foetal Doppler system

• Primary Device ID: 00888937019872
• NIH Device Record Key: e04cf9e3-2edb-4f56-951e-a2eea8ca9ba6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeDop® 150A Professional with 3.0 MHz Fetal Probe
• Version Model Number: DML150A-SD3
• Company DUNS: 801895244
• Company Name: Coopersurgical, 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: 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	00888937019872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K024197

FDA Product Code

• KNG: Monitor, Ultrasonic, Fetal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-09-28

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