SAFIRA

Basic Information

• Brand Name: SAFIRA
• Primary DI: 05060727270068
• Version / Model: SAFIRA Palm Operator
• Catalog Number: 900059
• Company Name: MEDOVATE LIMITED
• Labeler DUNS: 223136416
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-10
• Public Version: 2
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: a19078e3-3247-48ca-9c70-98603037732c

Device Description

SAFIRA System hand operator for controlling SAFIRA Driver

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58506	Pain management medication delivery system	An assembly of devices intended to be used by a healthcare professional (e.g., orthopaedist, pain management specialist, rheumatologist) for the intermittent delivery of liquid medication in a controlled manner to manage pain in various applications [e. g, intra-articular, epidural site(s), and nerve blocks]. It typically consists of a mains electricity (AC-powered) multichannel delivery pump, a disposable cassette, vial transfer spikes, and a handpiece/tubing set. The system automates aspects of the injection procedure otherwise performed by manual syringe and typically records treatment information for patient records; it may interface with an external ultrasound (US) system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060727270068	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K230083	000

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: 14 – 104 Degrees Fahrenheit