Epidural Disposable Kit

GUDID 00618874116019

MILESTONE SCIENTIFIC INC.

Electronic epidural space locator pressure-sensing set

• Primary Device ID: 00618874116019
• NIH Device Record Key: 8966ea35-077d-4464-b37b-caf4b9497411
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epidural Disposable Kit
• Version Model Number: EPI-6100
• Company DUNS: 006891188
• Company Name: MILESTONE SCIENTIFIC INC.
• Device Count: 10
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618874116019 [Unit of Use]
GS1	00618874116101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053554

FDA Product Code

• FRN: Pump, Infusion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-10
• Device Publish Date: 2022-09-30

On-Brand Devices [Epidural Disposable Kit]

• 20618874000220: EPI-6010
• 00618874116019: EPI-6100
• 00618874601010: Epidural Disposable Kit (pre-assembled)
• 00618874601102: Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System