Mediplus

GUDID 15055140700114

Silicone 2 way Foley catheter 16Fr

MEDIPLUS LTD

Indwelling urethral drainage catheter

• Primary Device ID: 15055140700114
• NIH Device Record Key: af42c617-7ecf-444c-af98-08d0b36de054
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediplus
• Version Model Number: 5766
• Company DUNS: 228480810
• Company Name: MEDIPLUS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk
• Phone: +4401494551200
• Email: help@mediplus.co.uk

Device Dimensions

• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French
• Length: 42 Centimeter
• Catheter Gauge: 16 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055140700117 [Primary]
GS1	15055140700114 [Package]; Contains: 05055140700117; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132890

FDA Product Code

• KOB: CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2018-09-24
• Device Publish Date: 2015-10-17

On-Brand Devices [Mediplus]

• 15055140703948: Capnomask™ DISS Connector Ophthalmic oxygen mask + CO2 sampling line 300cm with male/female co
• 15055140703931: Capnomask™ DISS Connector Paediatric Oxygen mask + CO2 sampling line 300cm with male/female co
• 15055140703924: Capnomask™ DISS Connector Paediatric Oxygen mask + CO2 sampling line 300cm with male/male conn
• 15055140703917: Capnomask™ DISS Connector Adult Oxygen mask + CO2 sampling line 300cm with male/male connector
• 15055140703894: Capnomask™ DISS Connector Adult Oxygen mask + CO2 sampling line 300cm with male/female connect
• 15055140703887: Capnomask™ DISS Connector Ophthalmic oxygen mask + CO2 sampling line 300cm with male/male conn
• 15055140703856: Capnomask™ Ophthalmic oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tu
• 15055140703849: Capnomask™ Paediatric Oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tu
• 15055140703276: Twin Extension set, 150cm long
• 15055140703047: Extension Line with one way valve, 20cm
• 15055140703030: Pump tube set for urodynamics system - Albyn
• 15055140702842: Extension set 200cm long
• 15055140702835: Extension set 125cm long, red
• 15055140702828: Extension set 125cm long, blue
• 15055140702811: Anorectal response catheter, 14Fr
• 15055140702767: Extension set 100cm long
• 15055140702750: Extension set 50cm long
• 15055140702743: Extension set 25cm long
• 15055140702736: Extension set 15cm long
• 15055140702729: Extension set 5cm long
• 15055140702415: Exeter air filled micro balloon catheter, 6Fr
• 15055140702408: Pump tube set for urodynamics system - Mediwatch/Medtronic/Dantec
• 15055140702385: Gravity fill set, 1.8m, fir tree connector
• 15055140702378: Gravity fill set, 1.8m, luer lock connector
• 15055140702361: Pump tube set for Sedia urodynamics system
• 15055140702330: Pump tube set for MMS Libra, Libraplus & Solar
• 15055140702323: Pump tube set for urodynamics system - MMS UD2000
• 15055140702316: Pump tube set for urodynamics system - Neomedix
• 15055140702293: Pump tube set for urodynamics system - Laborie
• 15055140702279: Pump tube set for urodynamics system - Lectromed/SIEM
• 15055140702217: Double lumen cystometry catheter, 6 Fr. Standard
• 15055140702200: Double lumen cystometery catheter, 8f, Standard
• 15055140702194: Double lumen UPP catheter, 6fr, with Y connector
• 15055140702170: Double lumen cystometry catheter, 6fr, short line
• 15055140702163: Double lumen cystometry catheter, 6fr
• 15055140702125: Double lumen cystometry catheter, 10fr
• 15055140702118: Double lumen UPP catheter, 8fr., extended lines
• 15055140702101: Double lumen UPP catheter, 7fr, with Y connector
• 15055140702095: Double lumen UPP catheter, 8fr
• 15055140702088: Double lumen cystometry catheter, 8fr
• 15055140702019: Catheter flushing set, 3-way, 150cm
• 15055140702002: CystoAid
• 15055140701975: Rectal balloon catheter 10Fr, non-sterile
• 15055140701951: Rectal balloon catheter, 21Fr
• 15055140701944: Rectal balloon catheter 4.5Fr
• 15055140701937: Double lumen rectal balloon catheter 10fr
• 15055140701913: Rectal balloon catheter with introducer
• 15055140701906: Rectal balloon catheter 4.5Fr
• 15055140701890: Rectal balloon catheter, 4.5Fr.
• 15055140701883: Rectal catheter 4.5Fr, non-sterile