SURFLO

Basic Information

• Brand Name: SURFLO
• Primary DI: 34987350761072
• Version / Model: SV*21BLS
• 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: 258d42e0-01e4-4952-a6cf-56f7df90e3a6

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	54987350761076	GS1		5	In Commercial Distribution	2024-03-29
Primary	34987350761072	GS1
Unit of Use	04987350761071	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	0.75	Inch
Total Volume	0.20	Milliliter
Device Size Text, specify			Needle Gauge 21 Gauge
Device Size Text, specify			Tubing Length 3.5 Inch

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