Intracardiac Sucker

Basic Information

• Brand Name: Intracardiac Sucker
• Primary DI: 08033178004695
• Version / Model: S361-50
• Company Name: SORIN GROUP ITALIA SRL
• Labeler DUNS: 442126587
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-03-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e2f4a4b2-4558-42c5-afaa-73ebfe9dc8c7

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: No
• 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
DTS	SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS	Cardiovascular	870.4420	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34923	Suction system catheter, general-purpose	A sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	38033178004696	GS1	BOX	10	In Commercial Distribution
Primary	08033178004695	GS1

Premarket Submissions

Submission Number	Supplement Number
K900339	000