FDA.reportPublic FDA data

Indwelling urethral catheterization kit

Definition
A collection of sterile devices that includes an indwelling urethral catheter (commonly known as a Foley catheter), gloves, lubricating gel, and other related accessories intended for the drainage of urine from the bladder. The catheter has an inflatable balloon at the distal tip for retention in the urinary bladder after its insertion through the urethra, where it usually functions as an indwelling therapeutic device for urinary incontinence or as a means to void for non-ambulatory patients. The catheter will be applied by trained staff and may or may not be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.
GUDID devices
569
Last updated
2020-11-09 16:06:00

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20884521001296DoverCardinal Health, Inc.7016C2016-09-24
20884521015545DoverCardinal Health, Inc.6165C2016-09-24
30884521001668DoverCardinal Health, Inc.25402016-09-24
10801741147484Bardex® I.C Complete Care® Temp-Sensing Foley Catheter with Urine MeterC. R. Bard, Inc.MT319416AM2020-08-06
00827002179394CookCOOK INCORPORATEDG179392017-08-09
10850005165009Biotronix Healthcare Foley TraysBIOTRONIX HEALTHCARE INDUSTRIES, INC.UR1428FT2019-10-04
10864085000495Biotronix Healthcare Foley TraysBIOTRONIX HEALTHCARE INDUSTRIES, INC.UR1416FT2019-10-05
20884521003528DoverCardinal Health, Inc.18142016-09-24
20884521003566DoverCardinal Health, Inc.18172016-09-24
20884521003580DoverCardinal Health, Inc.18182016-09-24
30884521001224DoverCardinal Health, Inc.7006ICLL2016-09-24
30884521003402DoverCardinal Health, Inc.2116IC2016-09-24
30884521003419DoverCardinal Health, Inc.2118IC2016-09-24
30884521009145DoverCardinal Health, Inc.6146ICLL2016-09-24
30884521009169DoverCardinal Health, Inc.6148ICLL2016-09-24
30884521015573DoverCardinal Health, Inc.6947LF2016-09-24
30884521015610DoverCardinal Health, Inc.7006IC2016-09-24
30884521015627DoverCardinal Health, Inc.7008IC2016-09-24
10801741147460SureStep Foley Tray System with Bard Lubri-Sil Temp Sensing Foley CatheterC. R. Bard, Inc.MTA119216M2019-05-23
10801741147477SureStep Foley Tray System with Bardex Lubricath Foley CatheterC. R. Bard, Inc.MTA9029162019-05-23
10801741147491SureStep Foley Tray System Bardex All-Silicone Foley CatheterC. R. Bard, Inc.MTA9024162019-05-23
40888277324610MedlineMEDLINE INDUSTRIES, INC.URO4PVCPC12MC2016-10-14
40888277331632MedlineMEDLINE INDUSTRIES, INC.DYNCX18162016-10-14
40889942125747MedlineMEDLINE INDUSTRIES, INC.URO1704162016-10-14
40889942126003MedlineMEDLINE INDUSTRIES, INC.URO1704182016-10-14
40889942126775MedlineMEDLINE INDUSTRIES, INC.URO170516S2016-10-14
40889942126799MedlineMEDLINE INDUSTRIES, INC.URO170518S2016-10-14
15019517061826Level 1ICU MEDICAL, INC.Urine Meter Foley Tray with Temperature2016-07-22
15019517061833Level 1ICU MEDICAL, INC.Urine Meter Foley Tray with Temperature2016-07-22
20612479101320McKessonMCKESSON MEDICAL-SURGICAL INC.37-2312016-12-09
20612479107780McKessonMCKESSON MEDICAL-SURGICAL INC.37-2022016-12-09
20852732004047Duette™POIESIS MEDICAL, LLCK-100162017-01-27
10884521003934DoverCardinal Health, Inc.88847311002016-09-24
10884521003989DoverCardinal Health, Inc.88847313002018-06-30
30884521001767DoverCardinal Health, Inc.30572016-09-24
30884521001941DoverCardinal Health, Inc.62512016-09-24
30884521009503DoverCardinal Health, Inc.750302016-09-24
10884521029590DoverCardinal Health, Inc.P4P16SD2016-09-24
10884521057739DoverCardinal Health, Inc.P4P16TS2016-09-24
20884521057774CovidienCardinal Health, Inc.UM400182016-09-24
10884521067004DoverCardinal Health, Inc.P4P14ULD2016-09-24
10884521154292DoverCardinal Health, Inc.69502016-09-24
10884521154308DoverCardinal Health, Inc.P4P18TS2016-09-24
10884521157026DoverCardinal Health, Inc.88847302002018-06-27
20884521174839CovidienCardinal Health, Inc.UM400162016-09-24
10884521612310DoverCardinal Health, Inc.P4P10SD2017-09-07
B150372020MCKESSONNURSE ASSIST, INC.37-2022016-09-24
B150372024NURSE ASSISTNURSE ASSIST, INC.37-2022016-09-24
B150372310MCKESSONNURSE ASSIST, INC.37-2312016-09-24
B150372314MCKESSONNURSE ASSIST, INC.37-2312016-09-24
B150372320MCKESSONNURSE ASSIST, INC.37-2322016-09-24
B150372324MCKESSONNURSE ASSIST, INC.37-2322016-09-24
B15072010NURSE ASSISTNURSE ASSIST, INC.72012016-09-24
B15072014NURSE ASSISTNURSE ASSIST, INC.72012016-09-24
B15072020NURSE ASSISTNURSE ASSIST, INC.72022016-09-24
B15072024NURSE ASSISTNURSE ASSIST, INC.72022016-09-24
B15073010NURSE ASSISTNURSE ASSIST, INC.73012016-09-24
B15073014NURSE ASSISTNURSE ASSIST, INC.73012016-09-24
B15073020NURSE ASSISTNURSE ASSIST, INC.73022016-09-22
B15073024NURSE ASSISTNURSE ASSIST, INC.73022016-09-24
B15074010NURSE ASSISTNURSE ASSIST, INC.74012016-09-22
B15074014NURSE ASSISTNURSE ASSIST, INC.74012016-09-24
B15074020NURSE ASSISTNURSE ASSIST, INC.74022016-09-22
B15074024NURSE ASSISTNURSE ASSIST, INC.74022016-09-24
B15075010NURSE ASSISTNURSE ASSIST, INC.75012016-09-22
B15075014NURSE ASSISTNURSE ASSIST, INC.75012016-09-24
B15075020NURSE ASSISTNURSE ASSIST, INC.75022016-09-22
B15075024NURSE ASSISTNURSE ASSIST, INC.75022016-09-24
00842209105373NAR KitNORTH AMERICAN RESCUE, LLC83-00202018-09-14
10855308006042DirectVisionPERCUVISION LLCMA1001432016-09-23
00863970000469TMM-FC (Tactical Medical Module - Foley Catheter)Altitude Technologies Inc.50062018-05-15
40872237005107GLOBAL HEALTHCAREGlobal Healthcare60-T1652017-02-10
40872237005114GLOBAL HEALTHCAREGlobal Healthcare60-T1852017-02-10
40872237008160GLOBAL HEALTHCAREGlobal Healthcare60-T16522017-02-10
40872237008177GLOBAL HEALTHCAREGlobal Healthcare60-T18522017-02-10
10801741000260Bardex® I.C. Complete Care® Foley TrayC. R. Bard, Inc.300016A2016-07-23
10801741000284Bard® Foley Tray with Bardex® Lubricath® Foley CatheterC. R. Bard, Inc.8996162016-06-13
10801741019293Bard® Criticore® Foley Tray with Bardex® Lubricath® Temp Sensing CatheterC. R. Bard, Inc.9002162016-06-13
10801741019309Bard® Criticore® Foley Tray with Bardex® Lubricath® Temp Sensing CatheterC. R. Bard, Inc.9002182016-06-13
10801741019316Bard® Criticore® Foley Tray with Bardex® Lubricath® Temp Sensing CatheterC. R. Bard, Inc.9004162016-06-13