FDA.reportPublic FDA data

HIgH-Flo™ Needle Set

Primary DI
00659443000247
Brand
HIgH-Flo™ Needle Set
Company
REPRO MED SYSTEMS, INC.
Model
RMS12609
Catalog number
RMS12609
Device description
26 Gauge Needle Sets - 1 needle - 9 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
10659443000244PackageGS120In Commercial Distribution
00659443000247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065944300024410659443000244
00659443000247006594430002476594430002470659443000247

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
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
00659443000438HIgH-Flo™ Needle SetRMS52604RMS526042016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04038917423410Safety-Multifly® 23G w.holderSarstedt Aktiengesellschaft & Co.KGFPA2024-02-20
08436020769177DOSI-FLOWLEVENTON SAUFPA2023-09-08
08436020769184DOSI-FLOWLEVENTON SAUFPA2023-09-08
07613117017422Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017446Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017460Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017484Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017507Soft-Release-MicroYpsomed AGFPA2020-09-15
07613117017521Soft-Release-MicroYpsomed AGFPA2020-09-15
08498840009338VYGONVygon CorporationFPA2020-04-21
08498840009895VYGONVygon CorporationFPA2020-04-21
08498840006535VYGONVygon CorporationFPA2020-03-12
04038917423892Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-12-13
04038917423724Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423755Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423762Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423779Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423786Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423793Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-10-06
04038917423885Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423915Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423922Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423939Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423960Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423977Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917423991Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30
04038917424004Safety-Multifly®-NeedleSarstedt Aktiengesellschaft & Co.KGFPA2019-09-30