SURFLO

Basic Information

• Brand Name: SURFLO
• Primary DI: 36927675516344
• Version / Model: SV25ELF
• Catalog Number: SV25ELF
• Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.
• Labeler DUNS: 544830912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2023-08-11
• Public Version: 1
• Public Version Date: 2023-08-21
• Public Version Status: New
• Public Device Record Key: 55bc730d-e561-495b-9c3f-61bab41539f4

Device Description

SURFLO Winged Infusion Set

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: Yes
• MRI Safety: MR Conditional
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65416	Basic intravenous administration set, invasive	A collection of devices which includes a hypodermic needle (e.g., venous butterfly/scalp vein needle) intended to conduct fluids from an intravenous (IV) fluid container to a patient's venous system during administration; it may also be used for blood collection. In addition to the needle, the set may include tubing, connectors, chambers, clamps, gauze pads, alcohol pads and dressings; a bag/bottle may also be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	56927675516348	GS1	Carton	10	In Commercial Distribution
Primary	36927675516344	GS1
Unit of Use	06927675516343	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K221411	000

Device Sizes

Type	Value	Unit	Text
Needle Gauge	25	Gauge
Device Size Text, specify			Type: Thin Wall (TW)
Device Size Text, specify			Tubing Length:8inch
Total Volume	0.30	Milliliter
Length	0.75	Inch

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: " DO NOT STORE AT EXTREME TEMPERATURES AND HUMIDITY.Keep away from sunlight.Stacking limit by 5.Fragile, handle with care.Keep dry."