FDA.reportPublic FDA data

Calibrated Reference Load 15 cm H2O.s/L (2 Years Edition)

Primary DI
07540261022807
Brand
Calibrated Reference Load 15 cm H2O.s/L (2 Years Edition)
Company
Thorasys Thoracic Medical Systems Inc
Model
102280
Device description
2 year valid Reference Load (15 cm H2O.s/L) to verify tremoflo Airwave Oscillometry System calibration.
Published
2026-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PNVImpedance Measuring Device Utilizing Oscillation Techniques

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PNVImpedance Measuring Device Utilizing Oscillation TechniquesAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170185000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170185000tremoFlo C-100 Airwave Oscillometry SystemThorasys Thoracic Medical Systems, Inc.2017-09-12PNV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540261022807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540261022807075402610228077540261022807

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary function analysis system, adultA device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].

Contacts#

Phone, Email table
PhoneEmail
+1-514-384-8555regulatory@thorasys.com

Regulatory Flags#

DUNS number
257777701
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540261016646tf C2 Sensor Module - clearflo1016642025-08-06
07540261017117tremoflo C2 Device - clearflo1017112025-08-06
07540261019470tremoflo C2 Reference Test Load1019472025-08-06
07540261020360tremoflo C2 Airwave Oscillometry System and Accessories1020362025-08-06
07540261022333tF C2 Sensor Module Labelled - Eco BVF1022332025-08-06
07540261022371tremoflo C2 Device - Yellow - VTG 285541022372025-08-06
07540261014215Clearflo PFT Filter in bag1014212018-01-16
07540261017612tf C-100 Kit Vitalograph - Clinical Trial Edition (28300)1017612024-09-20
07540261020698tF Calibrated Reference Load 15cmH2O (2 Years Edition)1020692024-09-20
07540261021107tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EU1021102024-09-20
07540261021817tf C-100 Kit Vitalograph - Healthcare Edition (28500)1021812024-09-20
07540261020797tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant Edition1020791020792024-04-12
07540261010590TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/L1010592021-11-03
07540261019234tremoflo C-100 Airwave Oscillometry - Support Arm1019232021-11-03
07540261025853tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US Edition1025852018-07-18
07540261009860TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/L1009862018-01-16
07540261013362tF C-100 Unit-ClearFlo PFT filter compatible1013362018-01-12
07540261013454tremoFlo US Software1013452018-01-16
07540261015243tremoflo C-100 Airwave Oscillometry System & Accesories - US Edition1015242018-01-16
07540261016400Assembly of tremoflo US software and digital user manual CD1016402018-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540261016646tf C2 Sensor Module - clearfloThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261017117tremoflo C2 Device - clearfloThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261019470tremoflo C2 Reference Test LoadThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261020360tremoflo C2 Airwave Oscillometry System and AccessoriesThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261022333tF C2 Sensor Module Labelled - Eco BVFThorasys Thoracic Medical Systems IncPNV2025-08-06
07540261022371tremoflo C2 Device - Yellow - VTG 28554Thorasys Thoracic Medical Systems IncPNV2025-08-06
07540261017612tf C-100 Kit Vitalograph - Clinical Trial Edition (28300)Thorasys Thoracic Medical Systems IncPNV2024-09-20
07540261020698tF Calibrated Reference Load 15cmH2O (2 Years Edition)Thorasys Thoracic Medical Systems IncPNV2024-09-20
07540261021107tremoflo C-100 Airwave Oscillometry System & Accessories - Ganshorn EUThorasys Thoracic Medical Systems IncPNV2024-09-20
07540261020797tremoflo C-100 Kit - Ganshorn SpiroDef Mouthpiece Variant EditionThorasys Thoracic Medical Systems IncPNV2024-04-12
07540261010590TremoFlo C-100 Calibrated Reference Load 15 cm H2O.s/LThorasys Thoracic Medical Systems IncPNV2021-11-03
07540261019234tremoflo C-100 Airwave Oscillometry - Support ArmThorasys Thoracic Medical Systems IncPNV2021-11-03
00860003953716PulmoScanCognita Labs, LLCPNV2021-03-08
07540261025853tremoflo C-100 Airwave Oscillometry System & Accesories - ERT US EditionThorasys Thoracic Medical Systems IncPNV2018-07-18
07540261009860TremoFlo C-100 Calibrated Reference Load 2 cm H2O.s/LThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261013454tremoFlo US SoftwareThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261014215Clearflo PFT Filter in bagThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261015243tremoflo C-100 Airwave Oscillometry System & Accesories - US EditionThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261016400Assembly of tremoflo US software and digital user manual CDThorasys Thoracic Medical Systems IncPNV2018-01-16
07540261013362tF C-100 Unit-ClearFlo PFT filter compatibleThorasys Thoracic Medical Systems IncPNV2018-01-12