ABTHERA™ SENSAT.R.A.C.™

GUDID 00849554001282

Abthera Open Abdomen Dressing with Sensatrac pad

KCI USA, INC.

Negative-pressure wound therapy open-abdomen dressing

• Primary Device ID: 00849554001282
• NIH Device Record Key: 731d8dcd-a9d5-4b46-92cf-b8d95b577f7d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ABTHERA™ SENSAT.R.A.C.™
• Version Model Number: M8275026/5
• Company DUNS: 102726734
• Company Name: KCI USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00849554000216 [Package]; Package: 5 PACK [5 Units]; In Commercial Distribution
GS1	00849554001282 [Primary]

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-15
• Device Publish Date: 2016-09-05

Devices Manufactured by KCI USA, INC.

• 00197998028939 - Solventum US LLC: 2025-08-06 Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
• 00197998028953 - Solventum US LLC: 2025-08-06 Solventum™ AbThera™ Advance Open Abdomen Dressing Kit, ABT1055, 5/CS
• 00197998032615 - Solventum US LLC: 2025-08-06 Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
• 00197998312274 - Solventum US LLC: 2025-08-06 Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC
• 00197998028809 - Solventum US LLC: 2025-07-31 Solventum™ Snap™ Therapy Strap, STPAS, Small, 1/CS
• 00197998028816 - Solventum US LLC: 2025-07-31 Solventum™ Snap™ Plus Therapy Strap, STPAMP, Medium, 1/CS
• 00197998028823 - Solventum US LLC: 2025-07-31 Solventum™ Snap™ Therapy Strap, STPAM, Medium, 1/CS
• 00197998028830 - Solventum US LLC: 2025-07-31 Solventum™ Snap™ Therapy Strap, STPALEE, Large, 1/CS