SURFLASH

Basic Information

• Brand Name: SURFLASH
• Primary DI: 34987350709746
• Version / Model: SR*FVP2032
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-09-14
• Public Version Status: Update
• Public Device Record Key: 61f41889-2834-43da-bab3-bd87e4e34f91
• Distribution End Date: 2018-08-29

Device Description

SURFLASH Plus

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	54987350709740	GS1		4	Not in Commercial Distribution	2018-08-29
Primary	34987350709746	GS1
Unit of Use	04987350709745	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	1.25	Inch
Device Size Text, specify			Catheter Gauge 20 Gauge

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Stacking limit by 5, Keep away from sunlight, Fragile, handle with care, Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Do not store at extreme temperature and humidity.