Prometheus

GUDID 15055140703863

Pathway Anorectal response catheter, 14Fr

MEDIPLUS LTD

Gastrointestinal manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic Gastrointestinal motility manometric catheter, non-electronic

• Primary Device ID: 15055140703863
• NIH Device Record Key: bbb49da4-2065-40ae-97e0-1128fe3a1566
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Prometheus
• Version Model Number: 7309
• 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

Device Dimensions

• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French
• Catheter Gauge: 14 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055140703866 [Primary]
GS1	15055140703863 [Package]; Contains: 05055140703866; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031617

FDA Product Code

• KLA: MONITOR, ESOPHAGEAL MOTILITY, AND TUBE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-20

Devices Manufactured by MEDIPLUS LTD

• 15055140704006 - Mediplus: 2021-11-29 Capnomask™ Adult Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm
• 15055140704013 - Mediplus: 2021-11-29 Capnomask™ Opthalmic Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm
• 15055140704020 - Mediplus: 2021-11-29 Capnomask™ Paediatric Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm
• 15055140704037 - Mediplus: 2021-11-29 Capnomask™ DISS Connector Adult Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm
• 15055140704044 - Mediplus: 2021-11-29 Capnomask™ DISS Connector Opthalmic Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm
• 15055140704051 - Mediplus: 2021-11-29 Capnomask™ DISS Connector Paediatric Oxygen mask + CO2 Microstream™ sampling line 300cm + O2 tube 200cm
• 15055140703887 - Mediplus: 2019-03-01 Capnomask™ DISS Connector Ophthalmic oxygen mask + CO2 sampling line 300cm with male/male connector + O2 tube 200cm
• 15055140703894 - Mediplus: 2019-03-01 Capnomask™ DISS Connector Adult Oxygen mask + CO2 sampling line 300cm with male/female connector + O2 tube 200cm