FDA.reportPublic FDA data

CATH-SECURE PLUS

Primary DI
00048329000257
Brand
CATH-SECURE PLUS
Company
M.C. JOHNSON CO., INC.
Model
5445-6
Device description
WATER RESISTANT MULTI-PURPOSE TUBE HOLDER
Published
2019-10-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10048329000254PackageGS150In Commercial Distribution
20048329000251PackageGS18In Commercial Distribution
00048329000257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004832900025410048329000254
2004832900025120048329000251
00048329000257000483290002570483290002570048329000257

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holder, single-useA device designed to be attached to a patient's body to hold an indwelling urinary catheter line (typically Foley) in place. It consists of a wrap or adhesive strip/pad, e.g., placed around the patient's thigh. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip). It is not designed to hold a urine collection bag. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
2394331538charlis@mcjohnson.com

Regulatory Flags#

DUNS number
112853395
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00048329000028CATH-SECURE PLUS with Skin Barrier Wipe54456P2021-01-06
00048329000035CATH-SECURE for Kids7334-22021-06-09
00048329000158CATH-SECURE Advanced54456ADV2021-06-09
00048329000196CATH-SECURE LOCK5445-12023-06-08
00048329000226CATH-SECURE5445-22019-10-01
00048329000233CATH-SECURE DUAL TAB5445-42020-01-02
00048329000240CATH-SECURE5445-32019-10-15
00048329000417M.C. JOHNSON NITRILE EXAM GLOVE X-SMALL (100ct)GNCFXS2023-06-09
00048329000448M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (100ct)GNCFS2023-06-09
00048329000479M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (100ct)GNCFM2023-06-09
00048329000509M.C. JOHNSON NITRILE EXAM GLOVE - LARGE (100ct)GNCFL2023-06-09
00048329000530M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (100ct)GNCFXL2023-06-09
00048329000738M.C. JOHNSON NITRILE EXAM GLOVE - X SMALL (250ct)GNCFXS2502023-06-09
00048329000745M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (250ct)GNCFS2502023-06-09
00048329000752M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (250ct)GNCFM2502023-06-09
00048329000769M.C. JOHNSON NITRILE EXAM GLOVE - LARGE (250ct)GNCFL2502023-06-09
00048329000776M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (250ct)GNCFXL2502023-06-09
00048329000424M.C. JOHNSON NITRILE EXAM GLOVE X-SMALL (100ct)GNCFXS2023-06-09
00048329000455M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (100ct)GNCFS2023-06-09
00048329000486M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (100ct)GNCFM2023-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253071054MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10192253071153MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
10885380211256MC JohnsonCardinal Health 200, LLCEYJ2026-05-20
00850067913009TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00850067913016TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
00612479280687McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281189McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281202McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281226McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281196McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479280717McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281219McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
00612479281233McKessonMCKESSON MEDICAL-SURGICAL INC.EYJ2026-01-20
05430004283522FlexGRIPBedalEYJ2025-12-03
05430004283782FlexGRIPBedalEYJ2025-12-03
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674284FlexGRIPBedalEYJ2025-12-01
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
00850058254333TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254364TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
00850058254371TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
50850058254376TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
20653160386367CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14
10653160386360CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14