StomaSoft Cleaning Swabs

Basic Information

• Brand Name: StomaSoft Cleaning Swabs
• Primary DI: 00848253004037
• Version / Model: TSWB10
• Catalog Number: TSWB10
• Company Name: Freudenberg Medical, LLC
• Labeler DUNS: 120981337
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-17
• Public Version: 2
• Public Version Date: 2025-11-05
• Public Version Status: Update
• Public Device Record Key: 79ee90cb-7cb7-4e12-883e-eb23f274752c

Device Description

The StomaSoft Cleaning Swabs are intended for cleaning tubes after removal from the patient.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	880.6025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62956	Airway device cleaning utensil, noninvasive, single-use	A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848253004037	GS1

Customer Contacts

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