SteriBreath™ Eco

Basic Information

• Brand Name: SteriBreath™ Eco
• Primary DI: 05060246860474
• Version / Model: SteriBreath™ Eco Mouthpiece
• Catalog Number: STERIBREATH-ECO
• Company Name: BEDFONT SCIENTIFIC LIMITED
• Labeler DUNS: 293959094
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-17
• Public Version: 1
• Public Version Date: 2026-03-25
• Public Version Status: New
• Public Device Record Key: 1418ca15-82a1-4fd5-bd05-024078f9a11a

Device Description

The SteriBreath™ Eco mouthpieces come in boxes of 200 mouthpieces, and each one is individually wrapped to ensure optimum infection control. The SteriBreath™ Eco Mouthpiece is entirely made from paper and therefore it is 100% recyclable and 100% biodegradable, including its packaging. Even better, all the materials are from sustainable sources.

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
CCJ	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	Anesthesiology	868.1430	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44545	Breathing mouthpiece, single-use	A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid plastic hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. It is typically attached, either directly or through other tubes/adaptors, to diagnostic and/or therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser, breath collector); connectors and filters may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060246860474	GS1

Premarket Submissions

Submission Number	Supplement Number
K173238	000