FDA.reportPublic FDA data

CATH-SECURE PLUS with Skin Barrier Wipe

Primary DI
10048329000025
Brand
CATH-SECURE PLUS with Skin Barrier Wipe
Company
M.C. JOHNSON CO., INC.
Model
54456P
Device description
WATER RESISTANT MULTI-PURPOSE MEDICAL TUBE HOLDER
Published
2021-01-06
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
10048329000025PackageGS140In Commercial Distribution
20048329000022PackageGS18In Commercial Distribution
00048329000028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004832900002510048329000025
2004832900002220048329000022
00048329000028000483290000280483290000280048329000028

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
239-433-1538charlis@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
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
00048329000516M.C. JOHNSON NITRILE EXAM GLOVE - LARGE (100ct)GNCFL2023-06-09
00048329000547M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (100ct)GNCFXL2023-06-09
10048329000735M.C. JOHNSON NITRILE EXAM GLOVE - X SMALL (250ct)GNCFXS2502023-06-09
10048329000742M.C. JOHNSON NITRILE EXAM GLOVE - SMALL (250ct)GNCFS2502023-06-09
10048329000759M.C. JOHNSON NITRILE EXAM GLOVE - MEDIUM (250ct)GNCFM2502023-06-09
10048329000766M.C. JOHNSON NITRILE EXAM GLOVE - LARGE (250ct)GNCFL2502023-06-09
10048329000773M.C. JOHNSON NITRILE EXAM GLOVE X-LARGE (250ct)GNCFXL2502023-06-09
10048329000193CATH-SECURE LOCK5445-12023-06-08
10048329000032CATH-SECURE for Kids7334-22021-06-09
10048329000131NG SECURE9304-12021-06-09
10048329000155CATH-SECURE Advanced54456ADV2021-06-09
20048329000350SHIELD SECURE1010-10172019-10-16
20048329000237CATH-SECURE DUAL TAB5445-42020-01-02
20048329000244CATH-SECURE5445-32019-10-15
20048329000251CATH-SECURE PLUS5445-62019-10-15
20048329000220CATH-SECURE5445-22019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850067913006TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
10850067913013TruLockHR PHARMACEUTICALS INC.EYJ2026-03-06
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
05430004283539FlexGRIPBedalEYJ2025-12-03
05430004283799FlexGRIPBedalEYJ2025-12-03
05430003674291FlexGRIPBedalEYJ2025-12-01
06009900639604Another HandWISMED PL SP Z O OEYJ2025-03-17
10850058254330TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10850058254361TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
50850058254376TruLockHR PHARMACEUTICALS INC.EYJ2025-03-03
10653160386360CenturionCENTURION MEDICAL PRODUCTS CORPORATIONEYJ2025-02-14
30618125134718Grip-LokPOSEY PRODUCTS, LLCEYJ2024-12-02
00618125192175Grip-LokTIDI PRODUCTS, LLCEYJ2024-12-02
20193489102724MEDLINEMEDLINE INDUSTRIES, INC.EYJ2024-09-19
10885632417115HalyardOWENS & MINOR DISTRIBUTION, INC.EYJ2024-07-29
G0960R867530959LineRising Eagle Medical LLCEYJ2024-01-30
80618125134782Grip-LokTIDI PRODUCTS, LLCEYJ2023-06-29
10048329000193CATH-SECURE LOCKM.C. JOHNSON CO., INC.EYJ2023-06-08
20193489102717MedlineMEDLINE INDUSTRIES, INC.EYJ2022-11-10
10618125135162Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-18
10618125134776Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
10618125134899Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
00618125134786Grip-LokTIDI PRODUCTS, LLCEYJ2022-10-13
00610570176519CHAS CATH-MATE STRAPBird & Cronin, LLCEYJ2022-08-30
00610570176526CATH-MATE II CATHETER STRAPBird & Cronin, LLCEYJ2022-08-30
00610570176786CHAS II CATH-MATE STRAPBird & Cronin, LLCEYJ2022-08-30
00610570187379CATH-MATE II X-LONG STRAP 28"Bird & Cronin, LLCEYJ2022-08-30