FDA.reportPublic FDA data

Vyaire

Primary DI
14250892904136
Brand
Vyaire
Company
Jaeger Medical GmbH
Model
36-PSA2000
Catalog number
36-PSA2000
Device description
MOUTHPIECE ADAPTOR
Published
2019-03-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K950197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950197000MICROCOMicro Direct, Inc.1996-10-17CCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14250892904136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1425089290413614250892904136

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+499314972127support.rt.eu@vyaire.com

Regulatory Flags#

DUNS number
329769991
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250892907352SentrySuite Software3.20V-7709652025-11-24
04250892908700Jaeger375119-13375119-132025-11-24
04250892908717Jaeger7066967066962025-11-24
04250892908731JaegerV-176420-13V-176420-132025-11-24
04250892908816Jaeger705560N705560N2025-11-24
04250892908823JaegerV-707525V-7075252025-11-24
04250892908861JaegerV-171470-13V-171470-132025-11-24
04250892908984JaegerV-577400-13V-577400-132025-11-24
04250892908991JaegerV-577084-13V-577084-132025-11-24
04250892909004Jaeger5.7V-770868-132025-11-24
04250892909059Jaeger28-835809-0012025-11-24
04250892909066Jaeger28-4b23795-0012025-11-24
14250892907243Jaeger36-NPROBETU2025-11-24
14250892907250Jaeger36-NPROBE0136-NPROBE012025-11-24
14250892907267Jaeger36-NPROBE0236-NPROBE022025-11-24
14250892907274Jaeger36-NPROBE0336-NPROBE032025-11-24
14250892907281Jaeger36-NPROBE0436-NPROBE042025-11-24
14250892908509Jaeger36-TDX105036-TDX10502025-11-24
14250892908905JaegerV-707183V-7071832025-11-24
14250892908929Jaeger36-PSA180036-PSA18002025-11-24

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
05060246860238D-Piece™BEDFONT SCIENTIFIC LIMITEDCCJ2026-03-17
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
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