CompuFlo Epidural Computer Controlled Anesthesia System

Basic Information

• Brand Name: CompuFlo Epidural Computer Controlled Anesthesia System
• Primary DI: 00618874116033
• Version / Model: EPI-6000-110
• Company Name: Milestone Scientific Inc.
• Labeler DUNS: 006891188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 1
• Public Version Date: 2023-06-21
• Public Version Status: New
• Public Device Record Key: 256d0eee-fc4e-4edf-b236-2765d1d5e446

Device Description

CompuFlo Epidural Computer Controlled Anesthesia System 110V

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61590	Electronic epidural space locator control unit	A mains electricity (AC-powered) device intended to be used with an epidural needle (not included) and an electronic epidural space locator pressure-sensing set, to aid a user in locating the epidural needle tip within the epidural space for subsequent anaesthesia administration. It consists of a user interface that provides acoustic and/or visual signals corresponding to the pressure at the needle tip.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00618874116033	GS1

Premarket Submissions

Submission Number	Supplement Number
K161883	000