V.A.C. VERAFLO™

Basic Information

• Brand Name: V.A.C. VERAFLO™
• Primary DI: 00849554001909
• Version / Model: ULTVFL05LG
• Company Name: KCI USA, INC.
• Labeler DUNS: 102726734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 5
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 9edea296-2210-42ee-889f-b23e7fb82305

Device Description

VAC Veraflo

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61145	Irrigation negative-pressure wound therapy dressing	A sterile dressing intended to treat open wounds (e.g., acute, traumatic, and chronic) that can only heal by secondary intention, through use of suction combined with instillation/aspiration of wound treatment solutions (e.g., saline) over the wound bed provided by an irrigation negative-pressure wound therapy unit. It typically consists of a foam dressing, polymer drape and attached tubing. It is intended to help reduce oedema, promote granulation tissue formation, and remove exudates and infectious material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849554001909	GS1
Package	00849554001893	GS1	5 Pack	5	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K100657	000