AVALON ELITE

Basic Information

• Brand Name: AVALON ELITE
• Primary DI: 04037691831039
• Version / Model: VAK
• Catalog Number: 70106.3540
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-13
• Public Version: 5
• Public Version Date: 2019-06-07
• Public Version Status: Update
• Public Device Record Key: 1347550f-2e07-4b6c-8a27-68b0bd976fdc

Device Description

Vascular Access Kit

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
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	870.1310	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58865	Vascular catheter introduction set, nonimplantable	A collection of sterile, nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04037691995434	GS1		5	In Commercial Distribution
Primary	04037691831039	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081940	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			OD dilator 26 French
Device Size Text, specify			Guidewire length 210 Centimeter
Device Size Text, specify			OD dilator 16 French
Device Size Text, specify			OD Guidewire 0.038 Inch
Device Size Text, specify			OD dilator 24 French
Device Size Text, specify			Syringe 10 Milliliter
Device Size Text, specify			OD dilator 12 French
Device Size Text, specify			OD dilator 10 French
Device Size Text, specify			OD dilator 20 French
Device Size Text, specify			OD dilator 30 French