CLEARVIEW®

Basic Information

• Brand Name: CLEARVIEW®
• Primary DI: 20885074257406
• Version / Model: 31125
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 006261481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2020-07-27
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 2e95eaf4-fed0-41ac-970d-fdcb02b8e8bf

Device Description

SHUNT 31125 ARTERIOTOMY 1.25MM 5PK 15LA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWF	Catheter, cannula and tubing, vascular, cardiopulmonary bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13586	Arteriovenous shunt	An implanted device designed to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. It is a synthetic vascular graft/graft assembly with a thin wall and appropriate size (commonly 6 mm diameter) and configuration to facilitate vessel puncturing. It is typically used when it is not possible or convenient to create a direct arteriovenous fistula or for patients who have exhausted peripheral venous access. Disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00885074257402	GS1
Primary	20885074257406	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120612	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	1.25	Millimeter