FDA.reportPublic FDA data

Mediplus

Primary DI
15055140701951
Brand
Mediplus
Company
MEDIPLUS LTD
Model
5450
Device description
Rectal balloon catheter, 21Fr
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGZACCESSORIES, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15055140701951PackageGS110In Commercial Distribution
05055140701954PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1505514070195115055140701951
05055140701954050551407019545055140701954

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge21French
Length35Centimeter

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
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 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
00840329837365BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
00840329837372BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
00840329837389BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08