FDA.reportPublic FDA data

S-Cath™

Primary DI
15055140701203
Brand
S-Cath™
Company
MEDIPLUS LTD
Model
5759
Device description
S-Cath™ System - Silicone suprapubic Foley (open tip) catheter, with introducer set, 16Fr. 10cc, 42cm
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
15055140701203PackageGS15In Commercial Distribution
05055140701206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505514070120315055140701203
05055140701206050551407012065055140701206

GMDN Terms#

Term, Definition table
TermDefinition
Suprapubic drainage catheterA sterile, flexible/semi-rigid tube intended to be inserted through a suprapubic (above the pubic arch) incision directly into the bladder of a male or female patient primarily for the drainage of urine, however it may also allow for infusion of fluid (e.g., medication, saline). It typically consists of a straight or angled, single-lumen tube which may have one of a variety of hole/tip configurations at the distal end (e.g., malecot or pigtail design). The proximal end remains external to the patient and has a connector for connection to a urine collection device. It may include a stiffening device to assist in its insertion. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
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
true
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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