enableCV ProPlege Peripheral Retrograde Cardioplegia Device

Basic Information

• Brand Name: enableCV ProPlege Peripheral Retrograde Cardioplegia Device
• Primary DI: 00840479400013
• Version / Model: PR9
• Catalog Number: PR9
• Company Name: ENABLECV INC.
• Labeler DUNS: 119247843
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-09
• Public Version: 1
• Public Version Date: 2025-04-17
• Public Version Status: New
• Public Device Record Key: d36d868d-8fd7-4cad-895f-2d25f0fcda8a

Device Description

ProPlege Peripheral Retrograde Cardioplegia Device

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
36109	Coronary sinus cannula	A sterile, rigid or semi-rigid tube designed to be surgically inserted, temporarily, into the ostium of the coronary sinus to provide retrograde coronary perfusion/cardioplegia during cardiopulmonary bypass or minimally invasive surgery. It may be equipped with a self-inflating low pressure balloon that is typically used for back flushing the coronary vessel in the event of inadvertent coronary air embolization. Insertion is achieved with the use of a removable stylet or trocar. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840479400013	GS1
Package	10840479400010	GS1	Case	1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K120780	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			9 Fr. (3.1 mm) x 23.2" (59 cm)

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store sterile packaged device in a cool dry place.