LiquID 061

Basic Information

• Brand Name: LiquID 061
• Primary DI: 00850012180005
• Version / Model: 6F
• Catalog Number: M1000
• Company Name: Seigla Medlcal Inc.
• Labeler DUNS: 035365243
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-14
• Public Version: 1
• Public Version Date: 2023-07-24
• Public Version Status: New
• Public Device Record Key: 75930d43-c857-47ed-8337-2b1b1cc9f31c

Device Description

Guide Catheter Extension

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: Yes
• 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
DQY	Catheter, Percutaneous	Cardiovascular	870.1250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64885	Vascular guide-catheter extension	A flexible tube designed to extend the length of a vascular guide-catheter during percutaneous transluminal passage and placement of a diagnostic/interventional device (e.g., pacing lead, balloon dilatation catheter) within either the coronary or peripheral vasculature. It is intended to be inserted through the lumen of the guide-catheter, and includes a proximal handle and delivery shaft connected to a distal catheter-extending tube. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850012180005	GS1

Premarket Submissions

Submission Number	Supplement Number
K220691	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French