SURFLO

Basic Information

• Brand Name: SURFLO
• Primary DI: 34806017512232
• Version / Model: SR-OX1832CA
• 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: 6e66e0e0-9229-48a2-8ef6-8978796ca5ec

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	54806017512236	GS1	Inner Carton	4	In Commercial Distribution
Primary	34806017512232	GS1
Package	74806017512230	GS1	Outer Carton	10	In Commercial Distribution
Unit of Use	14806017512238	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			18 Catheter Gauge
Length	1.25	Inch
Device Size Text, specify			Flow rate: 100 mL/min

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.