FDA.reportPublic FDA data

Subcutaneous infusion/injection port needle

Definition
A 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.
GUDID devices
415
Last updated
2026-09-29 04:02:15

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00369771003390Pen NeedleGERI-GENTLE CORPORATION11-3052023-09-01
00020221078404"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 19G X 1"""Exel International37840S2023-04-10
00020221078411"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 19G X 3/4"""Exel International37841S2023-04-10
00020221078442"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 20G X 1"""Exel International37844S2023-04-10
00020221078459"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 20G X 3/4"""Exel International37845S2023-04-10
00020221078466"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 20G X 1 1/2"""Exel International37846S2023-04-10
00020221078480"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 1"""Exel International37848S2023-04-10
00020221078497"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 3/4"""Exel International37849S2023-04-10
00020221078503"EXEL SAFETY+ HIS FIXED WING, NON-DEHP W/Y 22G X 1 1/2"""Exel International37850S2023-04-10
00020221078541"EXEL SAFETY+ HIS FIXED WING, NON-DEHP 20G X 1"""Exel International37854S2023-04-10
00020221078558"EXEL SAFETY+ HIS FIXED WING, NON-DEHP 20G X 3/4"""Exel International37855S2023-04-10
00020221078565"EXEL SAFETY+ HIS FIXED WING, NON-DEHP 20G X 1 1/2"""Exel International37856S2023-04-10
00020221078589"EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 1"""Exel International37858S2023-04-10
00020221078596"EXEL SAFETY+ HIS FIXED WING, NON-DEHP 22G X 3/4"""Exel International37859S2023-04-10
00020221079401"EXEL HIS ROTATING WING, NON-DEHP W/Y 19GX1"""Exel International27940R2023-04-07
00020221079418"EXEL HIS ROTATING WING, NON-DEHP W/Y 19GX3/4"""Exel International27941R2023-04-07
00020221079449"EXEL HIS ROTATING WING, NON-DEHP W/Y 20GX1"""Exel International27944R2023-04-07
00020221079456"EXEL HIS ROTATING WING, NON-DEHP W/Y 20GX3/4"""Exel International27945R2023-04-07
00020221079463"EXEL HIS ROTATING WING, NON-DEHP W/Y 20GX1-1/2"""Exel International27946R2023-04-07
00020221079487"EXEL HIS ROTATING WING, NON-DEHP W/Y 22GX1"""Exel International27948R2023-04-07
00020221079494"EXEL HIS ROTATING WING, NON-DEHP W/Y 22GX3/4"""Exel International27949R2023-04-07
00020221079500"EXEL HIS ROTATING WING, NON-DEHP W/Y 22GX1-1/2"""Exel International27950R2023-04-07
00020221079548"EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX1"""Exel International27954R2023-04-07
00020221079555"EXEL HIS ROTATING WING, NON-DEHP W/O Y 20GX3/4"""Exel International27955R2023-04-07
00020221079586"EXEL HIS ROTATING WING, NON DEHP W/O Y 22GX1"""Exel International27958R2023-04-10
00020221079593"EXEL HIS ROTATING WING, NON DEHP W/O Y22GX3/4"""Exel International27959R2023-04-10
00085412013480SUB-Q-SETBAXTER HEALTHCARE CORPORATION1M84632016-09-24
00610586023999DeltecICU MEDICAL, INC.21-2005-242015-09-01
00610586024002DeltecICU MEDICAL, INC.21-2006-242015-09-01
00610586024019DeltecICU MEDICAL, INC.21-2007-242015-09-01
00610586024026DeltecICU MEDICAL, INC.21-2008-242015-09-01
00610586024033DeltecICU MEDICAL, INC.21-2013-242015-09-01
00610586024040DeltecICU MEDICAL, INC.21-2014-242015-09-01
00610586024057DeltecICU MEDICAL, INC.21-2015-242015-09-01
00610586024064DeltecICU MEDICAL, INC.21-2016-242015-09-01
00610586024071DeltecICU MEDICAL, INC.21-2021-242015-09-01
00610586024088DeltecICU MEDICAL, INC.21-2287-242015-09-01
00610586024118DeltecICU MEDICAL, INC.21-2316-242015-09-01
00610586024125DeltecICU MEDICAL, INC.21-2317-242015-09-01
00610586028055DeltecICU MEDICAL, INC.21-2022-242015-09-01
00610586028062DeltecICU MEDICAL, INC.21-2026-242015-09-01
00610586028468DeltecICU MEDICAL, INC.21-2027-242015-09-01
00642621029239FlowEase [Subcutaneous] Infusion SetBaxalta US Inc.1M20062016-09-28
00642621029246FlowEase [Subcutaneous] Infusion SetBaxalta US Inc.1M20092016-09-28
00642621029253FlowEase [Subcutaneous] Infusion SetBaxalta US Inc.1M20122016-09-28
00659443000230HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS126042016-08-19
00659443000247HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS126092016-08-19
00659443000254HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS126062016-08-19
00659443000261HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS126122016-08-19
00659443000278HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS126142016-08-19
00659443000285HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS226042016-08-19
00659443000292HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS226062016-08-19
00659443000308HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS226092016-08-19
00659443000315HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS226122016-08-19
00659443000322HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS226142016-08-19
00659443000339HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS326042016-08-19
00659443000346HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS326062016-08-19
00659443000353HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS326092016-08-19
00659443000360HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS326122016-08-19
00659443000377HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS326142016-08-19
00659443000384HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS426042016-08-19
00659443000391HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS426062016-08-19
00659443000407HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS426092016-08-19
00659443000414HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS426122016-08-19
00659443000421HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS426142016-08-19
00659443000438HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS526042016-08-19
00659443000445HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS526062016-08-19
00659443000452HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS526092016-08-19
00659443000469HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS526122016-08-19
00659443000476HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS526142016-08-19
00659443000483HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS626042016-08-19
00659443000490HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS626062016-08-19
00659443000506HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS626092016-08-19
00659443000513HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS626122016-08-19
00659443000520HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS626142016-08-19
00659443000537HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS124062016-08-19
00659443000544HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS124092016-08-19
00659443000551HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS124122016-08-19
00659443000568HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS124142016-08-19
00659443000575HIgH-Flo™ Needle SetREPRO MED SYSTEMS, INC.RMS224062016-08-19