SURFLO

Basic Information

• Brand Name: SURFLO
• Primary DI: 34987350761010
• Version / Model: SV*27EL
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 5
• Public Version Date: 2023-11-16
• Public Version Status: Update
• Public Device Record Key: bd98a982-57f6-46d2-adef-5ac0673d10bc

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
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	54987350761014	GS1		10	In Commercial Distribution	2024-03-29
Primary	34987350761010	GS1
Unit of Use	04987350761019	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Tubing Length 8 Inch
Device Size Text, specify			Needle Gauge 27 Gauge
Length	0.5	Inch
Total Volume	0.29	Milliliter

Storage Conditions

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