FDA.reportPublic FDA data

Epidural Disposable Kit

Primary DI
00618874116101
Brand
Epidural Disposable Kit
Company
Milestone Scientific Inc.
Model
EPI-6100
Published
2022-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRNPump, Infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053554000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053554000COMPUFLOMilestone Scientific, Inc.2006-07-10FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00618874116101PrimaryGS10
00618874116019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618874116101006188741161016188741161010618874116101
00618874116019006188741160196188741160190618874116019

GMDN Terms#

Term, Definition table
TermDefinition
Electronic epidural space locator pressure-sensing setA collection of sterile devices intended to be used with an epidural needle (not included) and an electronic epidural space locator control unit, to aid a user in locating the epidural needle tip within the epidural space for subsequent anaesthesia administration. It typically consists of a pressure sensor, a syringe used to inject saline/air during the procedure to generate pressure, and tubing. This is a single-use device.

Regulatory Flags#

DUNS number
006891188
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
00618874116040CompuFlo Epidural Computer Controlled Anesthesia SystemEPI-6000-2202023-06-13
00618874601010Epidural Disposable Kit EPI-6010-012023-06-13
00618874112035CompuDent-STA™ Drive UnitSTA-51102023-06-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500835120017Avoset Optum Homecare InfusionOptum Distribution Center, LLCFRN2026-02-24
17290109155309Sapphire M.T. Pump Kit CEITAN MEDICAL LTDFRN2024-09-04
30815112021345Elution Test Vial Bracco Diagnostics Inc.FRN2024-02-13
10815112021396CardioGen-82 Infusion System Model 1700Bracco Diagnostics Inc.FRN2023-12-01
10815112021358CardioGen Patient Administration SetBracco Diagnostics Inc.FRN2023-10-16
17290109155149Sapphire Epidural Infusion Kit - US EITAN MEDICAL LTDFRN2023-09-05
30815112021338Accessory PackageBracco Diagnostics Inc.FRN2023-06-29
30815112020034Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
30815112020614Accessory PackageBracco Diagnostics Inc.FRN2023-03-22
17290109154272Sapphire Epidural Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-15
17290109154289Sapphire M.T Infusion Pump Kit- US - S kit EITAN MEDICAL LTDFRN2022-05-15
17290109154265Sapphire M.T Infusion Pump Kit – USEITAN MEDICAL LTDFRN2022-05-11
10814844000365Curlin IV Pump SystemZEVEX INTERNATIONAL, INC.FRN2021-04-29
15019517177367PharmGuardICU MEDICAL, INC.FRN2020-03-20
15019517177374PharmGuardICU MEDICAL, INC.FRN2020-03-20
10884521064843KangarooCardinal Health, Inc.FRN2019-12-30
15019517155143MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155150MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517155167MEDFUSIONICU MEDICAL, INC.FRN2019-09-20
15019517178067MedfusionICU MEDICAL, INC.FRN2019-09-18
20763000273334MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
20763000273358MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2019-09-02
M33513852011Plum 360ICU MEDICAL, INC.FRN2019-02-15
70643169771481MiniMed™ ReservoirMEDTRONIC MINIMED, INC.FRN2018-05-31
08050616611635APO-GO Syringe reservoirCANE' SPAFRN2018-05-28
17290109150229SapphirePlus Infusion Kit - USEITAN MEDICAL LTDFRN2018-02-22
09350902001614Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001690Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001720Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18
09350902001751Flow Control TubingGO MEDICAL INDUSTRIES PTY. LTD.FRN2017-05-18