ACTIV.A.C.™

GUDID 00849554001992

300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile

KCI USA, INC.

Negative-pressure wound therapy system canister

• Primary Device ID: 00849554001992
• NIH Device Record Key: a1e29831-94ed-48de-ac1c-add7b26844f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIV.A.C.™
• Version Model Number: M8275058/5 M8275058/10
• 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	00849554000940 [Package]; Package: 5 Pack [5 Units]; In Commercial Distribution
GS1	00849554000957 [Package]; Package: 10 Pack [10 Units]; In Commercial Distribution
GS1	00849554001992 [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: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-17
• Device Publish Date: 2016-09-05

On-Brand Devices [ACTIV.A.C.™ ]

• 00878237001486: 300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile
• 00849554001992: 300 ml Canister (with Gel) for Activac Therapy System Fluid Path Sterile
• 00849554015401: ACTIV.A.C. CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, None, 3M REBRANDING, NON STERILE