Zoom 6F Insert Catheter, VRT

Basic Information

• Brand Name: Zoom 6F Insert Catheter, VRT
• Primary DI: 00812212030627
• Version / Model: IC6FVRT137
• Catalog Number: IC6FVRT137
• Company Name: IMPERATIVE CARE, INC.
• Labeler DUNS: 080816678
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-18
• Public Version: 2
• Public Version Date: 2025-02-06
• Public Version Status: Update
• Public Device Record Key: 71585cb5-4945-441a-bf0a-25ddd52fc1c0

Device Description

Zoom 6F Insert Catheter, VRT, 137cm

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: Yes
• 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
Primary	00812212030627	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K233975	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	0.041	Inch
Outer Diameter	0.082	Inch
Catheter Length	137	Centimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place at room temperature.
• Type: Special Storage Condition, Specify
• Special Conditions: Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.