LifeDop® 250 ABI system with 2 cuffs, aneroid and printer

GUDID 00888937019919

LifeDop® 250 ABI system with 2 cuffs, aneroid and printer

Coopersurgical, Inc.

Noninvasive vascular ultrasound system, battery-powered

• Primary Device ID: 00888937019919
• NIH Device Record Key: 858442e5-7b8c-42c5-bca5-9d2ff86c4ffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LifeDop® 250 ABI system with 2 cuffs, aneroid and printer
• Version Model Number: DML250AB
• 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	00888937019919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093393

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

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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