V.A.C. Freedom™

GUDID 00849554006874

VAC Freedom Therapy Unit and Disposables Kit

KCI USA, INC.

Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00849554006874
• NIH Device Record Key: 29c9f221-f3fa-413d-ae71-00abe64e06ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V.A.C. Freedom™
• Version Model Number: FRE-KIT
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00849554006874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062227

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: 2018-08-17
• Device Publish Date: 2017-12-12

On-Brand Devices [V.A.C. Freedom™]

• 00849554005594: V.A.C. FREEDOM THERAPY UNIT
• 00878237001516: VAC FREEDOM THERAPY SYSTEM
• 00878237000977: Vac Freedom 300ml Canister with Gel
• 00849554006881: VAC Freedom Disposables Kit
• 00849554006874: VAC Freedom Therapy Unit and Disposables Kit