PRIORITYONE

Basic Information

• Brand Name: PRIORITYONE
• Primary DI: 04543334177261
• Version / Model: UG1652
• Catalog Number: 30-7100
• Company Name: TERUMO CLINICAL SUPPLY CO., LTD.
• Labeler DUNS: 691034748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-16
• Public Version: 6
• Public Version Date: 2022-11-09
• Public Version Status: Update
• Public Device Record Key: 1424f697-f4e0-414b-a3b5-79526ec87dbe

Device Description

PRIORITYONE Aspiration 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: 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
DXE	Catheter, Embolectomy	Cardiovascular	870.5150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58173	Thrombectomy suction catheter	A flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	74543334177260	GS1	Carton	2	In Commercial Distribution
Package	54543334177266	GS1	Carton	5	In Commercial Distribution
Primary	04543334177261	GS1
Package	14543334177268	GS1	Unit Box	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K112382	000

Device Sizes

Type	Value	Unit	Text
Length	140	Centimeter
Device Size Text, specify			Min. Guide Catheter I.D. 2.03Millimeter
Device Size Text, specify			Min. Guide Catheter I.D. 0.080Inch

Storage Conditions

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