CompuFlo Epidural Trainer 110V/220V

GUDID 00618874999995

CompuFlo Epidural Trainer

Milestone Scientific Inc.

Electronic epidural space locator control unit

• Primary Device ID: 00618874999995
• NIH Device Record Key: 849905b1-c5bf-468a-84a8-d2a950218f2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CompuFlo Epidural Trainer 110V/220V
• Version Model Number: EPI-6500T
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00618874999995 [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: false

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

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: 2023-06-22CompuFlo Epidural Trainer
• 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