FDA.reportPublic FDA data

HIgH-Flo™ Needle Set

Primary DI
00659443000520
Brand
HIgH-Flo™ Needle Set
Company
REPRO MED SYSTEMS, INC.
Model
RMS62614
Catalog number
RMS62614
Device description
26 Gauge Needle Sets - 6 needles - 14 mm
Published
2016-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122404000
K200176000
K211206000
K214045000
K252015000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122404000MODEL NUMBER: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26Repro-Med Systems, Inc. Dba Rms Medical Products2013-05-06FPA
K200176000FREEDOM Integrated Syringe Infusion SystemRepro-Med Systems, Inc. Dba Koru Medical Systems2021-12-15FRN
K211206000FreedomEdge(R) Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems2021-11-09FRN
K214045000FreedomEdge Syringe Infusion SystemRepro-Medical System, Inc., Dba Koru Medical Systems2022-04-29FRN
K252015000FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingKoru Medical Systems, Inc.2026-01-28FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10659443000527PackageGS110In Commercial Distribution
00659443000520PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065944300052710659443000527
00659443000520006594430005206594430005200659443000520

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous infusion/injection port needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be attached to a syringe and designed for the therapeutic injection or infusion of medicinal substances directly beneath the skin layer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge26Gauge

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)624-9600info@korumedical.com

Regulatory Flags#

DUNS number
048403299
Device count
1
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00659443000230HIgH-Flo™ Needle SetRMS12604RMS126042016-08-19
00659443000247HIgH-Flo™ Needle SetRMS12609RMS126092016-08-19
00659443000254HIgH-Flo™ Needle SetRMS12606RMS126062016-08-19
00659443000261HIgH-Flo™ Needle SetRMS12612RMS126122016-08-19
00659443000278HIgH-Flo™ Needle SetRMS12614RMS126142016-08-19
00659443000285HIgH-Flo™ Needle SetRMS22604RMS226042016-08-19
00659443000292HIgH-Flo™ Needle SetRMS22606RMS226062016-08-19
00659443000308HIgH-Flo™ Needle SetRMS22609RMS226092016-08-19
00659443000315HIgH-Flo™ Needle SetRMS22612RMS226122016-08-19
00659443000322HIgH-Flo™ Needle SetRMS22614RMS226142016-08-19
00659443000339HIgH-Flo™ Needle SetRMS32604RMS326042016-08-19
00659443000346HIgH-Flo™ Needle SetRMS32606RMS326062016-08-19
00659443000353HIgH-Flo™ Needle SetRMS32609RMS326092016-08-19
00659443000360HIgH-Flo™ Needle SetRMS32612RMS326122016-08-19
00659443000377HIgH-Flo™ Needle SetRMS32614RMS326142016-08-19
00659443000384HIgH-Flo™ Needle SetRMS42604RMS426042016-08-19
00659443000391HIgH-Flo™ Needle SetRMS42606RMS426062016-08-19
00659443000407HIgH-Flo™ Needle SetRMS42609RMS426092016-08-19
00659443000414HIgH-Flo™ Needle SetRMS42612RMS426122016-08-19
00659443000421HIgH-Flo™ Needle SetRMS42614RMS426142016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17
00827989008243MedSafetyHealth Care Logistics, Inc.FPA2026-07-10
05051684018473LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018480LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018497LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018503LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018510LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018527LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018534LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018541LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018558LifeportAngiodynamics, Inc.FPA2026-06-23
05051684018565LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018572LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018589LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018596LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018602LifeguardAngiodynamics, Inc.FPA2026-06-23
05051684018619LifeguardAngiodynamics, Inc.FPA2026-06-23