FDA.report

MMS

Primary DI
15055140703153
Brand
MMS
Company
MEDIPLUS LTD
Model
MMS5415i
Device description
Rectal balloon catheter with introducer
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
15055140703153PackageGS125In Commercial Distribution
05055140703156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1505514070315315055140703153
05055140703156050551407031565055140703156

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

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