FDA.reportPublic FDA data

D-Piece™

Primary DI
05060246860238
Brand
D-Piece™
Company
BEDFONT SCIENTIFIC LIMITED
Model
D-Piece™
Catalog number
D-PIECE-3
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.
Published
2026-03-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173238000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173238000ToxCOBedfont Scientific, Ltd.2019-04-04CCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060246860238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060246860238050602468602385060246860238

GMDN Terms#

Term, Definition table
TermDefinition
Gas sampling line filter, reusableA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
293959094
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060246860474SteriBreath™ EcoSteriBreath™ Eco MouthpieceSTERIBREATH-ECO2026-03-17
05060246860191NObreath®NObreath® MouthpieceNOBREATH-V2-MP502026-03-09
05060246860368GastrolyzerGastroCHECKGASTROCHECK2024-09-05
05060246860399GastrolyzerGastroGENIUSLMTCH42023-06-15
05060246860108GastrolyzerGastro+GASTRO2023-06-08
05060246860153GastrolyzerHydroGeniusLMTH22023-06-08
05060246860375GastrolyzerGastroCHECKGASTROCEHCK-US2020-03-12
05060246860177NOBreathNOBreath V2NOBREATH-V22022-01-06
05060246860320FeNOBreathFeNOBreathFENOBREATH-MGC2022-01-06
05060246860429iCO Quit SmokerlyzeriCO QuitICOQUIT2022-01-06
05060246860030ToxCOToxCOTOXCO-USA2020-03-12
05060246860047SmokerlyzerMicro+MICROADV2020-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858481006024CO Sensor ModuleCapnia, INC.CCJ2026-05-06
00858481006055CoSense Precision Sampling SetCapnia, INC.CCJ2026-05-06
05060246860474SteriBreath™ EcoBEDFONT SCIENTIFIC LIMITEDCCJ2026-03-17
14250892908929JaegerJaeger Medical GmbHCCJ2025-11-24
05060246860429iCO Quit SmokerlyzerBEDFONT SCIENTIFIC LIMITEDCCJ2022-01-06
15099169297507BreathCOVITALOGRAPH (IRELAND) LIMITEDCCJ2021-03-11
069364159026741-Slot CO2 Module w/ kit (Neo)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
069364159027591-Slot CO2/O2 Module w/ kit (Neo)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098432Sidestream CO2 module(FDA/FJ)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098449IBP_CO_SidestreamCO2 module(FDA)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098456IBP_CO_SidestreamCO2 module(FDA/FJ)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904098463Sidestream CO2 module(FDA)IIShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-10
06944904096803ORIDION CO2 mod upgrd kit,intlShenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-07
06944904096698single CO2 Module(accessory kit)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
06944904096759ORIDION CO2(Package/no accessory)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
06944904096810single CO2 Module(Neonate accessory kit)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
06944904098784115-046935-00Shenzhen Mindray Bio-Medical Electronics Co., Ltd.CCJ2020-05-06
05060246860030ToxCOBEDFONT SCIENTIFIC LIMITEDCCJ2020-03-12
05060246860047SmokerlyzerBEDFONT SCIENTIFIC LIMITEDCCJ2020-03-12
14250892904129VyaireJaeger Medical GmbHCCJ2019-05-28
00863571000318Pivot Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2019-04-25
08635710003014Pivot Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2019-04-25
14250892904136VyaireJaeger Medical GmbHCCJ2019-03-19
54250892905506VyaireJaeger Medical GmbHCCJ2019-03-19
14250892901838Micro MedicalJaeger Medical GmbHCCJ2018-05-11
14250892901869Micro MedicalJaeger Medical GmbHCCJ2018-05-11
54250892901362Micro MedicalJaeger Medical GmbHCCJ2018-03-31
54250892901584Micro MedicalJaeger Medical GmbHCCJ2018-03-31
00863571000301Carbon Monoxide Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2017-10-27
08635710003007Carbon Monoxide Breath Sensor CARROT INC. WHICH WILL DO BUSINESS IN CALIFORNIA AS CARROT BEHAVIORAL HEALTH INC.CCJ2017-10-27