CompuFlo Epidural

GUDID 00618874000219

MILESTONE SCIENTIFIC INC.

Electronic epidural space locator control unit

• Primary Device ID: 00618874000219
• NIH Device Record Key: 95f39eac-0b51-4608-9500-037de0a6bd3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompuFlo Epidural
• Version Model Number: EPI-6000-110
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618874000219 [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: false

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

Devices Manufactured by MILESTONE SCIENTIFIC INC.

• 00618874601034 - CathCheck Disposable Kit (Pre-assembled): 2023-06-22 CathCheck Disposable Kit (Pre-assembled) to be used with CompuFlo Epidural Computer Controlled Anesthesia System
• 00618874601102 - Epidural Disposable Kit: 2023-06-22 Epidural Disposable Kit for use with CompuFlo Epidural Computer Controlled Anesthesia System
• 00618874610012 - Epidural Disposable Box: 2023-06-22 Epidural Disposable Box of 10 units
• 00618874610036 - CathCheck Disposable Kit: 2023-06-22 CathCheck Disposable Kit box of 10 units to be used with CompuFlo Epidural Computer Controlled Anesthesia System
• 00618874999988 - Epidural Trainer Disposable Kit: 2023-06-22 EPI 6510T CompuFlo Epidural Trainer Disposable Kit
• 00618874999995 - CompuFlo Epidural Trainer 110V/220V: 2023-06-22 CompuFlo Epidural Trainer
• 00618874112042 - CompuDent STA Drive Unit: 2023-06-21 STA Instrument 220V
• 00618874116033 - CompuFlo Epidural Computer Controlled Anesthesia System: 2023-06-21 CompuFlo Epidural Computer Controlled Anesthesia System 110V