LiquID 061

Basic Information

• Brand Name: LiquID 061
• Primary DI: 00850012180029
• Version / Model: 6F
• Catalog Number: H74939736006 (M1001)
• 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: c1ad59b1-6f5f-4f92-a7f4-6e607c4a6077

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: 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
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	00850012180029	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220691	000

Device Sizes

Type	Value	Unit	Text
Catheter Gauge	6	French