AccessGUDID - DEVICE: CompuFlo Epidural Computer Controlled Anesthesia System (00618874116033)

GUDID

Device Identifier (DI) Information

Brand Name: CompuFlo Epidural Computer Controlled Anesthesia System
Version or Model: EPI-6000-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Milestone Scientific Inc.

Primary DI Number: 00618874116033
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 006891188 *Terms of Use

Device Description: CompuFlo Epidural Computer Controlled Anesthesia System 110V

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61590	Electronic epidural space locator control unit	A mains electricity (AC-powered) device intended to be used with an epidural needle (not included) and an electronic epidural space locator pressure-sensing set, to aid a user in locating the epidural needle tip within the epidural space for subsequent anaesthesia administration. It consists of a user interface that provides acoustic and/or visual signals corresponding to the pressure at the needle tip.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMF	Syringe, Piston

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161883	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 256d0eee-fc4e-4edf-b236-2765d1d5e446
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023