AVALON ELITE

Basic Information

• Brand Name: AVALON ELITE
• Primary DI: 04037691830711
• Version / Model: Avalon Elite BiCaval Dual Lumen Catheter
• Catalog Number: 70106.3538
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 601219ca-c526-437b-a0e6-463a1027d5ad

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
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40601	Peripheral vascular catheter	A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access; it is not intended to be advanced to the central vasculature. It typically includes dedicated accessories to facilitate catheter introduction/placement and function (e.g., connectors, injection ports, stylet and/or wings for fixation). It may be used for blood sampling, monitoring of blood pressure, to administer fluids, medication and/or for the injection of contrast media. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04037691830711	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081820	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Insertion length 31 Centimeter
Device Size Text, specify			Connectors 3/8 Inch
Catheter Gauge	31	French