FDA.report

MMS

Primary DI
15055140703146
Brand
MMS
Company
MEDIPLUS LTD
Model
MMS5415
Device description
Rectal balloon catheter 4.5Fr
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications

CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
15055140703146PackageGS125In Commercial Distribution
05055140703149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1505514070314615055140703146
05055140703149050551407031495055140703149

GMDN Terms

TermDefinition
Urodynamic measurement systemAn assembly of devices used for advanced diagnosis/study of the bladder. It is used to identify the cause of abnormal voiding, including incontinence and is useful for the diagnosis of, e.g., neurogenic bladder diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry (measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle activity). Long-term recording may also be analysed.

Device Sizes

TypeValueUnit
Catheter Gauge4.5French
Length200Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+4401494551200help@mediplus.co.uk

Regulatory Flags

DUNS number
228480810
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
15055140702804MediplusA202Ac2025-08-29
15055140704006MediplusA202Ax-M2021-11-19
15055140704013MediplusA202Cx-M2021-11-19
15055140704020MediplusA202Px-M2021-11-19
15055140704037MediplusA202Ax-D-M2021-11-19
15055140704044MediplusA202Cx-D-M2021-11-19
15055140704051MediplusA202Px-D-M2021-11-19
15055140703887MediplusA202CMX-D2019-01-29
15055140703894MediplusA202FX-D2019-01-29
15055140703917MediplusA202MX-D2019-01-29
15055140703924MediplusA202PMX-D2019-01-29
15055140703931MediplusA202PFX-D2019-01-29
15055140703948MediplusA202CFX-D2019-01-29
15055140700107Mediplus57642015-10-17
15055140700114Mediplus57662015-10-17
15055140701210Mediplus57672015-10-17
15055140701227Mediplus57692015-10-17
15055140701340Mediplus57622015-10-17
15055140701609Mediplus57652015-10-17
15055140700091S-Cath™57562015-10-17

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20653160392375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KGZ2026-02-26
06937440443811YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
06937440443828YiGaoMedZhejiang Yigao Medical Technology Co., Ltd.KGZ2025-12-09
40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
40704411017883AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
04048223118702FixoLongPajunk GmbH MedizintechnologieKGZ2025-04-04
05708932767811SopranoColoplast A/SKGZ2025-03-26
20192253053606DevonCardinal Health 200, LLCKGZ2025-03-25
20192253042020DevonCardinal Health 200, LLCKGZ2025-03-07
20192253042037DevonCardinal Health 200, LLCKGZ2025-03-07
00840306834936Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835155Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-11
00840306835124Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-12-10
00860012804405BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00860012804412BladeClearPATHWAY MEDTECH, LLCKGZ2024-11-04
00840306836039Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-23
10884521811546RitusCovidien LPKGZ2024-10-21
00840306835162Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835179Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835186Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835209Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835216Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835223Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835230Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
00840306835247Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2024-10-10
05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
50382904275650BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
50382904275612BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275629BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
50382904275636BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20