XVAC

Basic Information

• Brand Name: XVAC
• Primary DI: 04033817753070
• Version / Model: 100-120V
• Company Name: LivaNova Deutschland GmbH
• Labeler DUNS: 343225272
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d6165517-365d-4b06-a00f-166b189518bb

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: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
CAC	APPARATUS, AUTOTRANSFUSION	Anesthesiology	868.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36607	General-purpose suction system, pneumatic	An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials from a body cavity or lumen by means of suction. It generally consists of a suction pump powered by compressed air or oxygen from a hospital's central gas system, tubing, plastic/glass collection container(s), a vacuum gauge, a regulator, an overflow trap, a moisture filter, and possibly a microbial filter. The pressurized gas enables the pump to create a vacuum in the suction tubing, which is inserted into the body for the removal of materials into the collection container. This system can be used in a wide variety of hospital or other healthcare settings.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04033817753070	GS1

Premarket Submissions

Submission Number	Supplement Number
K110782	000