FDA.reportPublic FDA data

Epidural Disposable Kit

Primary DI
00618874601010
Brand
Epidural Disposable Kit
Company
Milestone Scientific Inc.
Model
EPI-6010-01
Device description
Epidural Disposable Kit (pre-assembled)
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00618874601010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00618874601010006188746010106188746010100618874601010

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006891188
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration 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
00618874116040CompuFlo Epidural Computer Controlled Anesthesia SystemEPI-6000-2202023-06-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530753944FD-1017NS - 1ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951FD-1018NS - 1ml PC Syringe - Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217FD-1078NS 20ml PC Syringe - White Plunger - Saline PrintDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620FD-1048NS 10ml PC Syringe Yellow Plunger LidocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699FD-1075NS 10ml PC Syringe Light Blue Plunger XylocaineDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941FD-1180NS 3ml Nugen Syringe Red PlungeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965FD-1162NS 10ml Nugen Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968FD-1019NS - 1ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088FD-1021NS 3ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754194FD-1034NS 20ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754224FD-1033NS 20ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530754231FD-1092NS 20ml PC Syringe Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-02
05391530753456FD-1032NS - 20ml PC Syringe Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753463FD-1031NS - 20ml PC Syringe White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753487FD-1113NS - 10ml PC Syringe Contrast Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753517FD-1051NS - 10ml PC Syringe Purple Plunger - Lidocaine PrintDMC MEDICAL LIMITEDFMF2026-06-01
05391530753524FD-1043NS - 10ml PC Syringe - Contrast - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753531FD-1107NS - 30ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753548FD-1026NS - 10ml PC Syringe - White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753555FD-1158NS - 10ml PC Syringe - Heparin/Saline White PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753562FD-1049NS - 10ml PC Syringe - Lidocaine Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753579FD-1029NS - 10ml PC Syringe Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753593FD-1054NS - 10ml PC Syringe - Nitro Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753609FD-1039NS - 10ml PC Syringe - Heparin Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753616FD-1071NS - 10ml PC Syringe - Purple PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753623FD-1028NS - 10ml PC Syringe - Yellow PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753647FD-1072NS - 10ml PC Syringe Dark Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753654FD-1030NS - 10ml PC Syringe - Light Green PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753661FD-1042NS - 10ml PC Syringe - Contrast Print - Light Blue PlungerDMC MEDICAL LIMITEDFMF2026-06-01
05391530753678FD-1044NS - 10ml PC Syringe - Contrast Print - Red PlungerDMC MEDICAL LIMITEDFMF2026-06-01