SAFIRA

Basic Information

• Brand Name: SAFIRA
• Primary DI: 05060727270037
• Version / Model: SAFIRA Syringe
• Catalog Number: 900016
• Company Name: MEDOVATE LIMITED
• Labeler DUNS: 223136416
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-20
• Public Version: 2
• Public Version Date: 2024-01-15
• Public Version Status: Update
• Public Device Record Key: 709858db-37f0-48e9-a49b-971997f305a3

Device Description

Sterile SAFIRA 20 mL syringe (Luer)

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• 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
Package	35060727270038	GS1	Cardboard box	20	In Commercial Distribution
Primary	05060727270037	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230083	000