Epidural Disposable Kit

Basic Information

• Brand Name: Epidural Disposable Kit
• Primary DI: 20618874000220
• Version / Model: EPI-6010
• Company Name: Milestone Scientific Inc.
• Labeler DUNS: 006891188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• 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: f75deabe-bb2b-4af0-a071-cffc9684edb5

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
Primary	20618874000220	GS1

Premarket Submissions

Submission Number	Supplement Number
K053554	000