V.A.C. VERAFLO™

GUDID 00849554001305

VAC Veraflo Dressing System Medium

KCI USA, INC.

Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing Irrigation negative-pressure wound therapy dressing

• Primary Device ID: 00849554001305
• NIH Device Record Key: 448ce995-a992-415f-9b23-394e83a7fa60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.C. VERAFLO™
• Version Model Number: ULTVFL05MD
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849554000155 [Package]; Package: 5 Pack [5 Units]; In Commercial Distribution
GS1	00849554001305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100657

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-22
• Device Publish Date: 2016-09-05

On-Brand Devices [V.A.C. VERAFLO™ ]

• 00849554004733: Vac Veraflo Cleanse Choice Dressing- Medium
• 00849554001909: VAC Veraflo
• 00849554001305: VAC Veraflo Dressing System Medium
• 00849554001299: Vac Veraflo Dressing System Small