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CompuFlo Epidural Computer Controlled Anesthesia System

FDA UDI

Class II (US FDA UDI)

by Milestone Scientific, Inc.

Identity

Trade Name
CompuFlo Epidural Computer Controlled Anesthesia System FDA UDI
Generic Name
Electronic epidural space locator control unit FDA UDI
Device Name
CompuFlo Epidural Computer Controlled Anesthesia System 220V FDA UDI
Model / Reference
EPI-6000-220 FDA UDI
Description
CompuFlo Epidural Computer Controlled Anesthesia System 220V FDA UDI

Identifiers

Primary DI / UDI-DI
00618874116040 FDA UDI
510(k) Number
K161883 FDA UDI
FDA Product Code
FMF FDA UDI
GMDN Term
Electronic epidural space locator control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.5860 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Electronic epidural space locator control unit

CompuFlo Epidural Computer Controlled Anesthesia System by Milestone Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electronic epidural space locator control unit.

Cleared under the same submission

K161883 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Milestone Scientific, Inc.

Sources (1)

  • FDA UDI 44eb0df3-6f0b-45fe-8848-32e546d4fd14 34 fields · synced May 30, 2026