V.A.C.ULTA™

Basic Information

• Brand Name: V.A.C.ULTA™
• Primary DI: 00849554001084
• Version / Model: CAPULTDEV01/US
• Company Name: KCI USA, INC.
• Labeler DUNS: 102726734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: bcebd5dd-67df-4468-a333-e990d629de0c

Device Description

VAC ULTA THERAPY SYSTEM

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61146	Irrigation negative-pressure wound therapy unit	A mains electricity (AC-powered) device designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) using suction combined with instillation/aspiration of wound treatment solutions (e.g., saline) over the wound bed. It typically includes controls and a user-interface to vary negative pressure and irrigation parameters, tubing, and a collection receptacle. It is intended to reduce oedema, promote granulation tissue formation, and remove exudates and infectious material.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	00849554001244	GS1
Primary	00849554001084	GS1

Premarket Submissions

Submission Number	Supplement Number
K100657	000