SURFLO

Basic Information

• Brand Name: SURFLO
• Primary DI: 34806017512270
• Version / Model: SR-OX2225CA
• Company Name: TERUMO (PHILIPPINES) CORPORATION
• Labeler DUNS: 718848773
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 4
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: c6a00d5f-7873-4aed-8977-82bce85afc7b

Device Description

SURFLO IV 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: Yes
• 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: 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	74806017512278	GS1	Outer Carton	10	In Commercial Distribution
Package	54806017512274	GS1	Inner Carton	4	In Commercial Distribution
Primary	34806017512270	GS1
Unit of Use	14806017512276	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133280	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Flow rate: 35 mL/min
Length	1	Inch
Device Size Text, specify			22 Catheter Gauge

Storage Conditions

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