Edwards

Basic Information

• Brand Name: Edwards
• Primary DI: 00690103217308
• Version / Model: 10000UP
• Catalog Number: 10000UPA
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-10
• Public Version: 1
• Public Version Date: 2023-07-18
• Public Version Status: New
• Public Device Record Key: c5923320-5b68-44db-9744-70bfdbb05a68

Device Description

Edwards Reusable Platform

Device Characteristics

• Single Use: No
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization Device	Cardiovascular	870.3955	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63544	Cardiac implantation catheter table base	A non-sterile, noninvasive, plate-like device designed to provide a flat surface on an operating table to support a table on which is placed the holder of a cardiac implant delivery catheter during delivery of a cardiac implant. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103217308	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a cool, dry place