CompuFlo Epidural Computer Controlled Anesthesia System

GUDID 00618874116033

CompuFlo Epidural Computer Controlled Anesthesia System 110V

Milestone Scientific Inc.

Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit Electronic epidural space locator control unit

• Primary Device ID: 00618874116033
• NIH Device Record Key: 256d0eee-fc4e-4edf-b236-2765d1d5e446
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompuFlo Epidural Computer Controlled Anesthesia System
• Version Model Number: EPI-6000-110
• Company DUNS: 006891188
• Company Name: Milestone Scientific 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: true
• Lot Batch: true
• 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	00618874116033 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161883

FDA Product Code

• FMF: Syringe, Piston

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: 2023-06-21
• Device Publish Date: 2023-06-13

On-Brand Devices [CompuFlo Epidural Computer Controlled Anesthesia System]

• 00618874116040: CompuFlo Epidural Computer Controlled Anesthesia System 220V
• 00618874116033: CompuFlo Epidural Computer Controlled Anesthesia System 110V