INFOV.A.C.™

GUDID 00849554006799

Infovac Therapy System

KCI USA, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00849554006799
• NIH Device Record Key: a232192e-9e35-4c27-a88d-e6f823f338a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INFOV.A.C.™
• Version Model Number: M8259999
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00849554001534 [Primary]
GS1	00849554006799 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063740

FDA Product Code

• OMP: Negative Pressure Wound Therapy Powered Suction Pump

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-20
• Device Publish Date: 2016-09-05

On-Brand Devices [INFOV.A.C.™ ]

• 00878237000915: 500 ml Canister (without Gel) for Infovac and VAC Ulta Therapy Systems
• 00878237000892: 500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
• 00849554002081: 500 ml Canister (without Gel) for Infovac and VAC Ulta Therapy Systems
• 00849554002074: 500 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
• 00849554002067: 1000 ml Canister (with Gel) for Infovac and VAC Ulta Therapy Systems
• 00849554006799: Infovac Therapy System