SURFLO MIDELA

Basic Information

• Brand Name: SURFLO MIDELA
• Primary DI: 36927675519857
• Version / Model: MCS1808D00F
• Catalog Number: MCS1808D00F
• Company Name: Terumo Medical Products (Hangzhou) Co., Ltd.
• Labeler DUNS: 544830912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• 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: 52637f75-ec68-4489-ae12-aad4b2a95d4f

Device Description

SURFLO MIDELA Midline 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
PND	Midline Catheter	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32151	Peripheral vascular intervention infusion catheter	A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	56927675519851	GS1	Large Unit box	5	In Commercial Distribution
Primary	36927675519857	GS1
Unit of Use	06927675519856	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K252402	000

Device Sizes

Type	Value	Unit	Text
Length	80	Millimeter
Catheter Gauge	1.3	French
Device Size Text, specify			1.3 MM

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not store at extreme temperatures.Fragile, handle with care. Keep away from sunlight. Keep dry .Stacking limit by 5.