Epidural Disposable Kit

Basic Information

• Brand Name: Epidural Disposable Kit
• Primary DI: 00618874116101
• Version / Model: EPI-6100
• Company Name: Milestone Scientific Inc.
• Labeler DUNS: 006891188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-09-30
• Public Version: 2
• Public Version Date: 2022-12-21
• Public Version Status: Update
• Public Device Record Key: 8966ea35-077d-4464-b37b-caf4b9497411

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61591	Electronic epidural space locator pressure-sensing set	A collection of sterile devices intended to be used with an epidural needle (not included) and an electronic epidural space locator control unit, to aid a user in locating the epidural needle tip within the epidural space for subsequent anaesthesia administration. It typically consists of a pressure sensor, a syringe used to inject saline/air during the procedure to generate pressure, and tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00618874116019	GS1
Primary	00618874116101	GS1

Premarket Submissions

Submission Number	Supplement Number
K053554	000