FDA.reportPublic FDA data

Intermittent urethral catheterization kit

Definition
A collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories (e.g., gloves, drapes, tray) intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. It is typically pre-lubricated or coated with, made of, or includes materials/substances that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass]; it might also be coated with or include antimicrobial materials/substances to help prevent infection of the urinary tract. This is a reusable device.
GUDID devices
101
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850005165019Biotronix Healthcare Urethral Catheter TraysBIOTRONIX HEALTHCARE INDUSTRIES, INC.UR220142019-10-04
00851616002014SteriGearSterigear, LLCRE4068P-012020-11-12
00851616002076SteriGearSterigear, LLCREA4094-012020-11-13
00851809002524TruCathHR PHARMACEUTICALS INC.CK102020-02-20
00851809002531TruCathHR PHARMACEUTICALS INC.CK122020-02-20
00851809002548TruCathHR PHARMACEUTICALS INC.CK142020-02-20
00851809002555TruCathHR PHARMACEUTICALS INC.CK162020-02-20
00851809002562TruCathHR PHARMACEUTICALS INC.CSC102020-02-20
00851809002579TruCathHR PHARMACEUTICALS INC.CSC122020-02-20
00851809002586TruCathHR PHARMACEUTICALS INC.CSC142020-02-20
00851809002609TruCathHR PHARMACEUTICALS INC.CSC162020-02-20
00872237008568GLOBAL HEALTHCAREGHC HEALTHCARE, INC.60-TN14012017-02-10
09350902001140O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.8 Gauge2017-05-17
09350902001188O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.12 Gauge2017-05-17
09350902001201O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.14 Gauge2017-05-17
09350902001225O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.16 Gauge2017-05-17
09350902001249O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.18 Gauge2017-05-17
10193489100273MedlineMEDLINE INDUSTRIES, INC.URO104412022-12-01
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.URO4PVCPC16C2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.URO4RR14C2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.URO4RR16C2025-04-02
10704411002383AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411002390AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003557AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
10704411003564AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
10704411003571AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
10704411003588AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
10704411003595AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
10704411003779AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003786AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003793AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003809AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003816AMSure® Pre-Connected Urethral TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003823AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003830AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411003847AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411005292AMSure® Add-A-Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411005308AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411005315AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411005322AMSure® Foley Catheter TrayAMSINO INTERNATIONAL, INC.12016-09-23
10704411007241AMSure® Add-A-Foley Catheter TrayAMSINO INTERNATIONAL, INC.12018-03-30
10704411007524AMSure® Urethral Catheterization Tray AMSINO INTERNATIONAL, INC.12018-04-28
10704411007531AMSure® Pre-Connected Urethral TrayAMSINO INTERNATIONAL, INC.12018-04-28
10704411007548AMSure® Pre-Connected Urethral TrayAMSINO INTERNATIONAL, INC.12018-04-28
10704411007555AMSure® Urethral Self Catheterization Kit 8Fr.AMSINO INTERNATIONAL, INC.12018-04-28
10704411007562AMSure® Urethral Self Catheterization Kit 10Fr.AMSINO INTERNATIONAL, INC.12018-04-28
10704411007579AMSure® Urethral Self Catheterization Kit 12Fr.AMSINO INTERNATIONAL, INC.12018-04-28
10704411007586AMSure® Urethral Self Catheterization Kit 14Fr.AMSINO INTERNATIONAL, INC.12018-04-28
10704411007593AMSure® Urethral Self Catheterization Kit 16Fr.AMSINO INTERNATIONAL, INC.12018-04-28
10704411007609AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12018-06-21
10704411007616AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12018-04-28
10704411007630AMSure® Urethral Catheterization Tray 15FrAMSINO INTERNATIONAL, INC.12018-04-25
10704411008026AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12018-05-30
10704411008033AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12018-05-30
10704411017776AMSure® Preconnected Urethral TrayAMSINO INTERNATIONAL, INC.12025-06-24
10888277719781MEDLINEMEDLINE INDUSTRIES, INC.URO4PVCPC14C2025-04-07
20197344148988MEDLINEMEDLINE INDUSTRIES, INC.URO4PVCPC16C2025-04-07
20888277719788MEDLINEMEDLINE INDUSTRIES, INC.URO4PVCPC14C2025-04-07
20197344148995MEDLINEMEDLINE INDUSTRIES, INC.URO4RR14C2025-04-02
20197344149008MEDLINEMEDLINE INDUSTRIES, INC.URO4RR16C2025-04-02
20193489100270MedlineMEDLINE INDUSTRIES, INC.URO104412022-12-01
09350902001157O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.8 Gauge2017-05-17
09350902001164O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.10 Gauge2017-05-17
09350902001195O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.12 Gauge2017-05-17
09350902001218O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.14 Gauge2017-05-17
09350902001232O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.16 Gauge2017-05-17
09350902001256O'Neil Intermittent Urinary CatheterGO MEDICAL INDUSTRIES PTY. LTD.18 Gauge2017-05-17
10704411007623AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12018-04-28
40704411002384AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12016-09-23
40704411002391AMSure® Foley Insertion TrayAMSINO INTERNATIONAL, INC.12016-09-23
40704411003558AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
40704411003565AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
40704411003572AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
40704411003589AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
40704411003596AMSure® Urethral Self Catheterization KitAMSINO INTERNATIONAL, INC.12016-09-23
40704411003770AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
40704411003787AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
40704411003794AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
40704411003800AMSure® Urethral Catheterization TrayAMSINO INTERNATIONAL, INC.12016-09-23
40704411003817AMSure® Pre-Connected Urethral TrayAMSINO INTERNATIONAL, INC.12016-09-23