FDA.reportPublic FDA data

CATH-SECURE

Primary DI
20048329000220
Brand
CATH-SECURE
Company
M.C. JOHNSON CO., INC.
Model
5445-2
Device description
MULTI-PURPOSE MEDICAL TUBE HOLDER
Published
2019-10-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
10048329000223PackageGS150In Commercial Distribution
20048329000220PackageGS18In Commercial Distribution
00048329000226PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004832900022310048329000223
2004832900022020048329000220
00048329000226000483290002260483290002260048329000226

GMDN Terms#

Term, Definition table
TermDefinition
Urinary catheter holderA device designed to be attached to a patient's body to hold an indwelling urinary catheter line (e.g., Foley) in place. It consists of a wrap or adhesive strip/pad placed around the patient's thigh, abdomen, or pubis. The holder includes appropriate mechanisms or attachments that can hold the tube or catheter (e.g., integrated Velcro hook, loop, clip) without creating excessive pressure on it and permitting visual inspection of the site. It is not designed to hold a urine collection bag. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2394331538charlis@mcjohnson.com

Regulatory Flags#

DUNS number
112853395
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
00048329000257CATH-SECURE PLUS5445-62019-10-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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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