V.A.C.ULTA™

GUDID 00849554000636

VAC ULTA THERAPY SYSTEM

KCI USA, INC.

Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit Irrigation negative-pressure wound therapy unit

• Primary Device ID: 00849554000636
• NIH Device Record Key: 7ad85630-d6d0-4e9f-9bb2-4eccc89c80da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.C.ULTA™
• Version Model Number: ULTDEV01/US
• 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	00849554000636 [Primary]
GS1	00849554001244 [Direct Marking]

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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-22
• Device Publish Date: 2016-09-24

On-Brand Devices [V.A.C.ULTA™]

• 00849554006775: Solution Container Hanger Arm Extension
• 00849554001244: VAC ULTA THERAPY SYSTEM
• 00849554000636: VAC ULTA THERAPY SYSTEM