Angios Classic Angiographic Convenience Kit

Basic Information

• Brand Name: Angios Classic Angiographic Convenience Kit
• Primary DI: 00885672101879
• Version / Model: ANG4-0238
• Catalog Number: ANG4-0238
• Company Name: Oscor Inc.
• Labeler DUNS: 101835833
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-16
• Public Version: 4
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d12769d0-e9f2-4e2e-ad40-51c28e4b618f
• Distribution End Date: 2018-05-10

Device Description

Angiographic Convenience Kit, 4F

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
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	00885672101879	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092118	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
Device Size Text, specify			Maximum Recommended Guidewire 0.038 in
Device Size Text, specify			Recommended Pressure Limit: 1200 psi max.
Device Size Text, specify			JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
Device Size Text, specify			Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
Device Size Text, specify			Flow Rate: JR: 18 mL/sec, JL: 18 mL/sec, PT: 18 mL/sec
Device Size Text, specify			Pigtail Side Holes: 5
Device Size Text, specify			Guidewire - Length: 150 cm, OD: 0.035 in

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius