Solventum US LLC

Basic Information

• Brand Name: Solventum US LLC
• Primary DI: 00197998312267
• Version / Model: M8275026/5
• Catalog Number: M8275026/5
• Company Name: KCI USA, INC.
• Labeler DUNS: 102726734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-29
• Public Version: 1
• Public Version Date: 2025-08-06
• Public Version Status: New
• Public Device Record Key: e07b0faa-8f22-43ae-a10f-986a1642a2c8

Device Description

Solventum™ AbThera™ SensaT.R.A.C.™ Open Abdomen Dressing Kit, M8275026/5, 5/PAC

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OMP	negative pressure wound therapy Powered suction pump	General, Plastic Surgery	878.4780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61147	Negative-pressure wound therapy open-abdomen dressing	A sterile dressing intended to be used on an open abdominal wall wound, with exposed viscera (e.g., abdominal compartment syndrome), to provide temporary wound bridging during negative-pressure wound therapy when primary closure is not possible and/or repeat abdominal entries are necessary. It typically consists of a nonadherent visceral protective layer, a perforated foam layer, an insulation layer to contain negative pressure, and tubing to connect to a negative-pressure wound therapy unit. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00197998312274	GS1	CASE	5	In Commercial Distribution
Primary	00197998312267	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]