SAFIRA 900044

GUDID 05060727270013

SAFIRA system foot operator for controlling SAFIRA Driver

MEDOVATE LIMITED

Pain management medication delivery system

• Primary Device ID: 05060727270013
• NIH Device Record Key: 784708b2-75ab-4be0-abc3-940cc35a67d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SAFIRA
• Version Model Number: SAFIRA Foot Pedal
• Catalog Number: 900044
• Company DUNS: 223136416
• Company Name: MEDOVATE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk
• Phone: +4401223901991
• Email: enquires@medovate.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060727270013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153599
• Premarket Notification: K230083

FDA Product Code

• FRN: Pump, Infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-28
• Device Publish Date: 2020-04-20

On-Brand Devices [SAFIRA]

• 35060727270038: Sterile SAFIRA 20 mL syringe (Luer)
• 05060727270020: SAFIRA Driver unit that injects/aspirates works in combination with SAFIRA Foot Pedal and SAFIRA
• 05060727270013: SAFIRA system foot operator for controlling SAFIRA Driver
• 35060727270052: Sterile SAFIRA 20 mL syringe (NRFit)
• 05060727270068: SAFIRA System hand operator for controlling SAFIRA Driver