FDA.report

CATH-SECURE DUAL TAB

Primary DI
20048329000237
Brand
CATH-SECURE DUAL TAB
Company
M.C. JOHNSON CO., INC.
Model
5445-4
Device description
MULTI-PURPOSE MEDICAL TUBE HOLDER
Published
2020-01-02
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

Related Records

Contact Domains

Product Codes

CodeName
EYJHolder, Ureteral Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
EYJHolder, Ureteral CatheterGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10048329000230PackageGS150In Commercial Distribution
20048329000237PackageGS18In Commercial Distribution
00048329000233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1004832900023010048329000230
2004832900023720048329000237
00048329000233000483290002330483290002330048329000233

GMDN Terms

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

Contacts

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

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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
10048329000025CATH-SECURE PLUS with Skin Barrier Wipe54456P2021-01-06
20048329000350SHIELD SECURE1010-10172019-10-16
20048329000244CATH-SECURE5445-32019-10-15
20048329000251CATH-SECURE PLUS5445-62019-10-15
20048329000220CATH-SECURE5445-22019-10-01

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