D-Piece™

Basic Information

• Brand Name: D-Piece™
• Primary DI: 05060246860238
• Version / Model: D-Piece™
• Catalog Number: D-PIECE-3
• 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: 16602b9c-0a6e-4538-a78b-13796a5dc96d

Device Description

The D-piece™ is intended to interface between the SteriBreath™ plastic single-use mouthpiece and the instrument. The D-piece™ has a push, interference fit connection to both the SteriBreath™ mouthpiece and the instrument and therefore can easily be disposed of and replaced if used with any patient group that poses a potential risk of cross infection. The D-Piece™ contains a one-way valve and bacterial filter to reduce the risk of cross infection. The D-Piece™ can be fitted to the instrument by the patient or health professional and can be used in any environment where breath analysis and lung function testing would normally be carried out.

Device Characteristics

• Single Use: No
• 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
64268	Gas sampling line filter, reusable	A screening device intended to be installed in a reusable gas sampling line or gas measuring instrument to remove and retain bacterial pathogens, and sometimes moisture, from the gas. It is designed to prevent a measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, bedside respiration monitor] and the system it is connected to (e.g., a breathing circuit) from becoming contaminated to reduce the risk of patient cross-contamination. Some types function as a water trap to help minimize damage to the measuring instrument from gas condensation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060246860238	GS1

Premarket Submissions

Submission Number	Supplement Number
K173238	000