V.A.C. VERAT.R.A.C. DUO™

GUDID 00849554001312

VAC Veralink Cassette

KCI USA, INC.

Negative-pressure wound therapy tubing set

• Primary Device ID: 00849554001312
• NIH Device Record Key: d15d1e34-24f1-491e-8c38-8cbe4b8590da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.C. VERAT.R.A.C. DUO™
• Version Model Number: ULTLNK0500
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	00849554000186 [Package]; Package: 5 PACK [5 Units]; In Commercial Distribution
GS1	00849554001312 [Primary]
GS1	00849554003231 [Package]; Package: 5 PACK [5 Units]; In Commercial Distribution

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: 5
• Public Version Date: 2018-08-22
• Device Publish Date: 2016-09-05

On-Brand Devices [V.A.C. VERAT.R.A.C. DUO™ ]

• 00849554001374: Vac Veratrac Duo Tube Set
• 00849554001329: Vac Veraflo Cleanse Dressing System
• 00849554001312: VAC Veralink Cassette