Epidural Disposable Kit

GUDID 00618874601102

Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System

Milestone Scientific Inc.

Electronic epidural space locator pressure-sensing set

• Primary Device ID: 00618874601102
• NIH Device Record Key: 968fceb5-4efa-40be-94a6-ac1bcb04065b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epidural Disposable Kit
• Version Model Number: EPI-6011
• 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: true
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618874601102 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-22
• Device Publish Date: 2023-06-14

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