D-Piece™ D-PIECE-3

GUDID 05060246860238

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.

BEDFONT SCIENTIFIC LIMITED

Gas sampling line filter, reusable
Primary Device ID05060246860238
NIH Device Record Key16602b9c-0a6e-4538-a78b-13796a5dc96d
Commercial Distribution StatusIn Commercial Distribution
Brand NameD-Piece™
Version Model NumberD-Piece™
Catalog NumberD-PIECE-3
Company DUNS293959094
Company NameBEDFONT SCIENTIFIC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060246860238 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-25
Device Publish Date2026-03-17

Devices Manufactured by BEDFONT SCIENTIFIC LIMITED

05060246860238 - D-Piece™2026-03-25The 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.
05060246860238 - D-Piece™2026-03-25 The D-piece™ is intended to interface between the SteriBreath™ plastic single-use mouthpiece and the instrument. The D-piece
05060246860474 - SteriBreath™ Eco2026-03-25 The SteriBreath™ Eco mouthpieces come in boxes of 200 mouthpieces, and each one is individually wrapped to ensure optimum infe
05060246860191 - NObreath®2026-03-17 Designed specifically for the NObreath® FeNO monitor, the NObreath® mouthpiece (FeNObreath Mouthpiece) contains an integrated
05060246860108 - Gastrolyzer2023-06-16 The Gastro+™ Gastrolyzer® product is a breath Hydrogen monitor used to measure hydrogen levels in expired breath. It is inten
05060246860153 - Gastrolyzer2023-06-16 The Hydrogenius® product is a breath Hydrogen monitor used to measure hydrogen levels in expired breath. It is intended for mul
05060246860030 - ToxCO2020-03-20 The ToxCO Breath Carbon Monoxide Monitor is used in the screening of Carbon Monoxide (CO) poisoning and calculation of the Carbo
05060246860047 - Smokerlyzer2020-03-20 The Micro+™ Smokerlyzer® product is a breath carbon monoxide monitor intended for multi-patient use by healthcare professiona
05060246860375 - Gastrolyzer2020-03-20 Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath.
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