VYAFUSER™

Basic Information

• Brand Name: VYAFUSER™
• Primary DI: 05713495000152
• Version / Model: VYAFUSER PUMP KIT US/PR A
• Catalog Number: 2089870410
• Company Name: Phillips-Medisize A/S
• Labeler DUNS: 306047440
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-13
• Public Version: 1
• Public Version Date: 2024-11-21
• Public Version Status: New
• Public Device Record Key: 22843d91-a8a9-4ad8-ac07-7ae0cd9cff45

Device Description

The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• 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
66485	Ambulatory syringe pump	A battery-powered ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency; it is not dedicated to insulin infusion. Sometimes referred to as a portable syringe driver, it consists of a small unit with a syringe driving mechanism. It is used with a suitable injection/infusion set for delivery of small/finite volumes via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be worn by the patient within and outside healthcare settings.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	05713495001043	GS1
Primary	05713495000152	GS1
Package	05713495000169	GS1	Multi Shipper Box	4	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.7	Inch
Width	3	Inch
Depth	1.3	Inch
Weight	285	Gram

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 53.3 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 41 – 104 Degrees Fahrenheit
• Type: Handling Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity