PASCAL

Basic Information

• Brand Name: PASCAL
• Primary DI: 00690103216974
• Version / Model: 20000ST
• Catalog Number: 20000STA
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-19
• Public Version: 1
• Public Version Date: 2022-09-27
• Public Version Status: New
• Public Device Record Key: d864de32-6128-4965-8890-5a1a0aec2100

Device Description

PASCAL SYSTEM - STABILIZER RAIL SYSTEM

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
NKM	Mitral Valve Repair Devices	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
63542	Cardiac implantation catheter holder	A sterile noninvasive device designed to externally support a cardiac implant delivery catheter to secure and position the catheter during delivery of a cardiac implant. It is fixed onto a dedicated catheter table and is typically a metallic or plastic structure with slots for fixing the catheter. It may be provided with additional supporting devices (e.g., the dedicated catheter table and table base). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103216974	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P220003	000

Storage Conditions

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