GLIDECATH

Basic Information

• Brand Name: GLIDECATH
• Primary DI: 04987350733382
• Version / Model: CG436
• Catalog Number: RF*ZIR4115JA
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-20
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 16826f4b-12b2-469d-9873-6c600afc018b

Device Description

RADIFOCUS GLIDECATH

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: 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
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	Cardiovascular	870.1200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10688	Angiographic catheter, single-use	A thin, flexible tube designed to inject a contrast medium into select blood vessels of the cerebral, visceral, or peripheral vasculature during an angiographic procedure in order to facilitate the clear visualization of the vascular system of a targeted organ or area of the body. It is introduced percutaneously, has a radiopaque marker(s) for positioning, and may include disposable devices dedicated to catheter introduction/function [e.g., sheath(s)]. It may also be used for simultaneous pressure measurements to determine the transvalvular, intravascular, and intraventricular pressure gradients. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34987350733383	GS1	Shelfbox	5	In Commercial Distribution
Primary	04987350733382	GS1
Package	54987350733387	GS1	Carton	5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.40	Millimeter
Pressure	5171	KiloPascal
Device Size Text, specify			Hydrophilic Coating Length : 40cm
Length	150	Centimeter
Device Size Text, specify			Max Guide Wire O.D. : .038" (0.97mm)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.