FDA.reportPublic FDA data

CompuFlo Epidural Computer Controlled Anesthesia System

Primary DI
00618874116040
Brand
CompuFlo Epidural Computer Controlled Anesthesia System
Company
Milestone Scientific Inc.
Model
EPI-6000-220
Device description
CompuFlo Epidural Computer Controlled Anesthesia System 220V
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161883000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161883000CompuFlo Epidural Computer Controlled Anesthesia SystemMilestone Scientific, Inc.2017-06-09FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618874116040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618874116040006188741160406188741160400618874116040

GMDN Terms#

Term, Definition table
TermDefinition
Electronic epidural space locator control unitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006891188
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00618874601133CathCheck Disposable KitEPI-6011-032025-01-17
00618874601034CathCheck Disposable Kit (Pre-assembled)EPI-6010-032023-06-14
00618874601102Epidural Disposable KitEPI-60112023-06-14
00618874610012Epidural Disposable Box EPI-6100-012023-06-14
00618874610036CathCheck Disposable KitEPI-6100-032023-06-14
00618874999988Epidural Trainer Disposable KitEPI-6510T 2023-06-14
00618874999995CompuFlo Epidural Trainer 110V/220VEPI-6500T2023-06-14
00618874112042CompuDent STA Drive UnitSTA-52202023-06-13
00618874116033CompuFlo Epidural Computer Controlled Anesthesia SystemEPI-6000-1102023-06-13
00618874601010Epidural Disposable Kit EPI-6010-012023-06-13
00618874112035CompuDent-STA™ Drive UnitSTA-51102023-06-12
00618874116101Epidural Disposable KitEPI-61002022-09-30
00618874000219CompuFlo EpiduralEPI-6000-1102022-09-30
20618874000220Epidural Disposable KitEPI-60102022-09-30
10618874000025the Wand STA HandpieceSTA-5050A2018-01-26
10618874000032the Wand STA HandpieceSTA-5050-27252018-01-26
10618874000049the Wand STA HandpieceSTA-5050-3012018-01-26
10618874000056the Wand STA HandpieceSTA-5050-3052018-01-26
10618874000063Safety Wand STA HandpieceSTA-5040ASAF2018-01-26
10618874000070Saftey Wand STA HandpieceSTA-5040 SAF-27252018-01-26

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Primary DI, Brand, Company table
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05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
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06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14