ACTIV.A.C. ™ iOn PROGRESS™

GUDID 00849554005600

Activac Therapy System IonProgress Remote Therapy Monitoring

KCI USA, INC.

Negative-pressure wound therapy system pump, electric

• Primary Device ID: 00849554005600
• NIH Device Record Key: b8219c24-6672-4780-8d21-d2594ac4a473
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIV.A.C. ™ iOn PROGRESS™
• Version Model Number: RTMGSM01/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	00849554005600 [Direct Marking]
GS1	00849554005617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063692

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: 2016-10-20

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