ABTHERA™

Basic Information

• Brand Name: ABTHERA™
• Primary DI: 00849554001275
• Version / Model: 370642
• Company Name: KCI USA, INC.
• Labeler DUNS: 102726734
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-05
• Public Version: 4
• Public Version Date: 2020-09-09
• Public Version Status: Update
• Public Device Record Key: 521c503b-21a5-4ddd-899a-19d17a3dff40

Device Description

Abthera Tubing Set

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: No
• 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
47409	Negative-pressure wound therapy tubing set	A collection of sterile, flexible, plastic tubing and associated items (e.g., connectors, line clamp, negative pressure applicator pad, canister) intended to be used as part of a vacuum-assisted wound closure system; commonly known as negative pressure wound therapy (NPWT). It is designed to create an airtight connection between the open-cell foam dressing and drape at the wound site and the vacuum pump. The tubing allows negative pressure to be delivered to the wound site and provides a conduit to channel excess interstitial fluid, wound exudate, and infectious materials from the wound to the collection canister. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849554001275	GS1
Package	00849554000230	GS1	5 Pack	5	In Commercial Distribution