CooperSurgical®

GUDID 00888937027822

Doppler Blood Flow Monitor

Coopersurgical, Inc.

Vascular ultrasound system control unit

• Primary Device ID: 00888937027822
• NIH Device Record Key: db522b2f-7a3b-439b-9776-fa4d8f043d8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CooperSurgical®
• Version Model Number: DP-M350
• 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: 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	00888937027822 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110347

FDA Product Code

• DPW: Flowmeter, Blood, Cardiovascular

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: 2025-10-03
• Device Publish Date: 2025-09-25

Devices Manufactured by Coopersurgical, Inc.

• 00888937027822 - CooperSurgical®: 2025-10-03Doppler Blood Flow Monitor
• 00888937027822 - CooperSurgical®: 2025-10-03 Doppler Blood Flow Monitor
• 00888937027884 - LapSac: 2025-09-11 LapSac Surgical Tissue Pouch (2”x5”)
• 20888937027895 - LapSac: 2025-09-11 LapSacTM Surgical Tissue Pouch (4”x6”)
• 20888937027901 - LapSac: 2025-09-11 LapSac Surgical Tissue Pouch (5” x 8”)
• 20888937027918 - LapSac: 2025-09-11 LapSacTM Surgical Tissue Pouch (8”x10”)
• 05060488046858 - EZ-Strip: 2025-04-21 Assisted Reproduction Microtools (Pipettes)
• 05060488046865 - EZ-Strip: 2025-04-21 Assisted Reproduction Microtools (Pipettes)
• 05060488046872 - EZ-Strip: 2025-04-21 Assisted Reproduction Microtools (Pipettes)