SAFIRA 900059
GUDID 05060727270068
SAFIRA System hand operator for controlling SAFIRA Driver
MEDOVATE LIMITED
Pain management medication delivery system| Primary Device ID | 05060727270068 |
| NIH Device Record Key | a19078e3-3247-48ca-9c70-98603037732c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAFIRA |
| Version Model Number | SAFIRA Palm Operator |
| Catalog Number | 900059 |
| 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 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk | |
| Phone | +4401223901991 |
| enquires@medovate.co.uk |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 500 millibar and 1060 millibar |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 104 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060727270068 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
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 | 2021-12-22 |
| Device Publish Date | 2021-12-10 |
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 |
Trademark Results [SAFIRA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SAFIRA 88343741 not registered Live/Pending |
ICA Independent Capital Advisors SA 2019-03-18 |
 SAFIRA 86503386 not registered Dead/Abandoned |
Philhobar Design Canada Ltd. 2015-01-14 |
 SAFIRA 85571193 4229782 Dead/Cancelled |
Sorrenti Inspirations Limited 2012-03-16 |
 SAFIRA 79281159 not registered Live/Pending |
Medovate Limited 2020-01-24 |
 SAFIRA 75862503 not registered Dead/Abandoned |
Safira Consulting & Communication 1999-12-02 |
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