ACTIV.A.C. ™

GUDID 00878237008188

Activac Therapy System

KCI USA, INC.

Negative-pressure wound therapy system, battery-powered, reusable

• Primary Device ID: 00878237008188
• NIH Device Record Key: a905de3a-0ec6-46df-af45-e11119475ce3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTIV.A.C. ™
• Version Model Number: 340000
• 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	00849554000285 [Primary]
GS1	00878237001813 [Primary]
GS1	00878237008188 [Direct Marking]

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: 2016-09-24

Devices Manufactured by KCI USA, INC.

• 00849554008632 - 3M™ Snap™: 2024-10-03 3M™ Snap™ Therapy Strap, STPAM, Medium, 1 Each/Case
• 00849554008618 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Therapy Strap, STPAS, Small, 1 Each/Case
• 00849554008656 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Therapy Strap, STPAL, Large, 1 Each/Case
• 00849554008670 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPASP, Small, 1 Each/Case
• 00849554008694 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1 Each/Case
• 00849554008717 - 3M™ Snap™: 2024-08-19 3M™ Snap™ Plus Therapy Strap, STPALP, Large, 1 Each/Case
• 00849554011762 - 3M™ V.A.C.®: 2024-08-19 ACTIV.A.C., CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, BSI MDR, 3M REBRANDING
• 00849554015401 - ActiV.A.C.™: 2024-08-08 ACTIV.A.C. CANISTER WITH GEL 10/CASE, ATHLONE, IH1078249, None, 3M REBRANDING, NON STERILE