SURFLO HYBRIA

Basic Information

• Brand Name: SURFLO HYBRIA
• Primary DI: 36927675526367
• Version / Model: SH20252321AF
• Catalog Number: SH20252321AF
• 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: 2026-04-01
• Public Version: 1
• Public Version Date: 2026-04-09
• Public Version Status: New
• Public Device Record Key: d3e52a49-fcb4-40da-bd0f-b141c452647b

Device Description

SURFLO HYBRIA Closed I.V. Catheter

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
64574	Peripheral intravenous cannula	A short, thin tube intended to be inserted into a peripheral vein (typically on the hand/arm) to enable short-term (< 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. Also referred to as a peripheral IV catheter, it is typically assembled with a dedicated introduction needle, and usually includes connectors, injection ports, and wings for fixation. It is not intended to be advanced to the central vasculature. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	56927675526361	GS1	Large Unit box	4	In Commercial Distribution
Primary	36927675526367	GS1
Unit of Use	06927675526366	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K252398	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			1.1 MM
Catheter Gauge	1	French
Length	25	Millimeter
Device Size Text, specify			FLOWRATE 58ML/MIN

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to water, direct sunlight, extreme temperature, or high humidity during storage.Fragile, handle with care. Keep dry. Keep away from sunlight. Stacking limit by 8.