TruFit™ Adhesive Housing, 6 Pack

GUDID 00848253003931

Freudenberg Medical, LLC

Tracheostomy base plate, single-use

• Primary Device ID: 00848253003931
• NIH Device Record Key: 04805456-fcaa-4955-b9d5-f35b58a7c269
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TruFit™ Adhesive Housing, 6 Pack
• Version Model Number: BE 6088-6
• Company DUNS: 120981337
• Company Name: Freudenberg Medical, LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com
• Phone: 800-477-5969
• Email: InHealth@inhealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848253003931 [Unit of Use]
GS1	00848253003955 [Primary]

FDA Product Code

• BYD: Condenser, Heat And Moisture (Artificial Nose)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-09
• Device Publish Date: 2025-04-01

Devices Manufactured by Freudenberg Medical, LLC

• 00848253003948 - TruFit™ Adhesive Housing, 30 Pack: 2025-04-09
• 00848253003931 - TruFit™ Adhesive Housing, 6 Pack: 2025-04-09
• 00848253003931 - TruFit™ Adhesive Housing, 6 Pack: 2025-04-09
• 00848253004013 - Cleaning Brush, Standard: 2025-04-02
• 00848253004020 - Cleaning Brush, Long: 2025-04-02
• 00848253004037 - StomaSoft Cleaning Swabs: 2025-03-25 The StomaSoft Cleaning Swabs are intended for cleaning tubes after removal from the patient.
• 00848253004006 - Blom-Singer® Nasal Septal Perforation Sizing Tool: 2025-03-24 The Nasal Septal Perforation Sizing Tool (NSPST) is a graded handheld device designed to measure nasal septal perforations. The
• 00848253002347 - InHealth Technologies; Blom-Singer: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 8mm length
• 00848253002354 - InHealth Technologies; Blom-Singer®: 2023-11-13 Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 10mm length