FDA.reportPublic FDA data

Mediplus

Primary DI
15055140700107
Brand
Mediplus
Company
MEDIPLUS LTD
Model
5764
Device description
Silicone 2 way Foley catheter 14Fr
Published
2015-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOBCATHETER, SUPRAPUBIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOBCatheter, Suprapubic (And Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132890000SUPRAPUBIC CATHETER AND INTRODUCER SETMediplus , Ltd.2014-01-17KOB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15055140700107PackageGS110In Commercial Distribution
05055140700100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505514070010715055140700107
05055140700100050551407001005055140700100

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral drainage catheterA sterile, flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, to function as an indwelling therapeutic device for urinary drainage; it might be designed to also allow for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge14French
Length42Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4401494551200help@mediplus.co.uk

Regulatory Flags#

DUNS number
228480810
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05055140704061S-Cath™5759-L2025-10-10
05055140702807MediplusA202Ac2025-08-29
15055140702804MediplusA202Ac2025-08-29
05055140700490Mediplus22702016-09-16
05055140700513Mediplus22722016-09-16
05055140700537Mediplus22742016-09-16
05055140700681Mediplus51042016-09-16
05055140700759Mediplus23152016-09-16
05055140700773Mediplus23202016-09-16
05055140701107Mediplus2300E2016-09-16
05055140701114Mediplus2244-1E2016-09-16
05055140701121Mediplus51052016-09-16
05055140701138Mediplus59012016-09-16
05055140701237Mediplus58322016-09-16
05055140701855Mediplus53332016-09-16
05055140701954Mediplus54502016-09-16
05055140702005Mediplus56102016-09-16
05055140702012Mediplus56202016-09-16
05055140702272Mediplus5801/12016-09-16
05055140702296Mediplus58062016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842071153069AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-04-28
00842071150952AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071150976AMT MiniSPC Drainage SetAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152758MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152765MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152772MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152789MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152796MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152802MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152819MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152826MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152833MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152840MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152857MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152864MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152871MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152888MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152895MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152901MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152918MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071152925MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-18
00842071149932MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149949MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149956MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149963MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149970MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149987MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071149994MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16
00842071150006MiniSPC ButtonAPPLIED MEDICAL TECHNOLOGY, INC.KOB2026-03-16