SURSHIELD

Basic Information

• Brand Name: SURSHIELD
• Primary DI: 34987350705700
• Version / Model: SR*SFF2025A
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2024-04-26
• Public Version: 1
• Public Version Date: 2024-05-06
• Public Version Status: New
• Public Device Record Key: f6f4f6a9-2aa1-4e38-bdc3-8832325a143b

Device Description

SURSHIELD-PUR SAFETY 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 Unsafe
• 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	54987350705704	GS1	Carton	4	In Commercial Distribution
Primary	34987350705700	GS1
Unit of Use	04987350705709	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.1	Millimeter
Lumen/Inner Diameter	0.8	Millimeter
Device Size Text, specify			Flow rate
Length	1	Inch
Catheter Gauge	20	French
Device Size Text, specify			Lumen volume of catheter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature and avoid excessive heat and humidity.
• Type: Special Storage Condition, Specify
• Special Conditions: Fragile, handle with care.