FDA.reportPublic FDA data

ERT PT

Primary DI
04057155000955
Brand
ERT PT
Company
eResearchTechnology GmbH
Model
ERT PT
Device description
Pneumotachograph tube, accessory, single-patient use
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTYCalculator, Predicted Values, Pulmonary Function

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTYCalculator, Predicted Values, Pulmonary FunctionAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173937000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173937000SpiroSphereEresearchtechnology GmbH2019-02-15BTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057155000955PackageGS110In Commercial Distribution
04057155000962PackageGS150In Commercial Distribution
04057155000948PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057155000955040571550009554057155000955
04057155000962040571550009624057155000962
04057155000948040571550009484057155000948

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometer, professionalAn electrically-powered device designed exclusively for professional use to measure several or all respiratory gas volume and flow parameters for evaluation of basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]; it may also perform pulse oximetry. It is typically a hand-held instrument with a mouthpiece which communicates with a computerized unit (e.g., analysis system, graph recorder, tablet). It is used to help diagnosis and monitoring of chronic pulmonary disorders such as asthma, emphysema, or bronchitis, and potentially heart disorders.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4993057209891CustomerCare@clario.com

Regulatory Flags#

DUNS number
341625331
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057155000948ERT PTERT PT2025-08-11
04057155000825SpiroSphereSpiroSphere Main Unit7074072024-12-03
04057155000801SpiroWaySpiroWay2024-07-22
04057155000580SpiroSphereSpiroSphere ECG2024-07-22
04057155000597SpiroSphereCardioSphere2024-07-22
04057155000665SpiroSphereSpiroSphere ECG CT2024-07-22
04057155000672SpiroSphereCardioSphere CT2024-07-22
04057155000689SpiroSphereSpiroSphere Standard ECG2024-07-22
04057155000696SpiroSphereCardioSphere Standard2024-07-22
04057155000795iSpiro Ultrasonic SensoriSpiro Ultrasonic Sensor2024-07-22
04057155000818SpiroWaySpiroWay2024-07-22
04057155000177Asthma Monitor AM1+AM1+2016-07-15
04057155000412ERT PTERT PT2019-02-25
04057155000771SpiroSphereSpiroSphere Main Unit7074062022-12-19
04057155000788SpiroSphereSpiroSphere CT1513132022-12-19
04057155000337RotationsflowgeberRotationsflowgeber2019-07-22
04057155000719SpiroSphereSpiroSphere Main Unit2021-02-18
04057155000726SpiroSphereSpiroSphere CT2021-02-18
04057155000757SpiroSphereSpiroSphere2021-02-18
04057155000764SpiroSphereSpiroSphere Standard2021-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
050991693321579100 VITALOGRAPH VitaloLAB+VITALOGRAPH (IRELAND) LIMITEDBTY2026-06-02
00850000967328SpiroLoopCMI HEALTH INC.BTY2026-03-06
00850000967625SpiroLink 2 ProCMI HEALTH INC.BTY2026-03-06
04250892908816JaegerJaeger Medical GmbHBTY2025-11-24
04250892908861JaegerJaeger Medical GmbHBTY2025-11-24
04250892909059JaegerJaeger Medical GmbHBTY2025-11-24
04250892909066JaegerJaeger Medical GmbHBTY2025-11-24
34250892908633JaegerJaeger Medical GmbHBTY2025-10-31
04250892908304JaegerJaeger Medical GmbHBTY2025-10-31
04250892908311JaegerJaeger Medical GmbHBTY2025-10-31
04250892908328JaegerJaeger Medical GmbHBTY2025-10-31
04250892908618JaegerJaeger Medical GmbHBTY2025-10-31
34250892908213JaegerJaeger Medical GmbHBTY2025-08-18
04057155000948ERT PTeResearchTechnology GmbHBTY2025-08-11
14250892909117JaegerJaeger Medical GmbHBTY2025-08-11
14250892907670JaegerJaeger Medical GmbHBTY2025-07-29
14250892907687JaegerJaeger Medical GmbHBTY2025-07-29
14250892907694JaegerJaeger Medical GmbHBTY2025-07-29
14250892907700JaegerJaeger Medical GmbHBTY2025-07-29
14250892907748JaegerJaeger Medical GmbHBTY2025-07-29
14250892907755JaegerJaeger Medical GmbHBTY2025-07-29
14250892907571JaegerJaeger Medical GmbHBTY2025-07-24
14250892907526JaegerJaeger Medical GmbHBTY2025-07-23
14250892907533JaegerJaeger Medical GmbHBTY2025-07-23
14250892907557JaegerJaeger Medical GmbHBTY2025-07-23
14250892907564JaegerJaeger Medical GmbHBTY2025-07-23
14250892907588JaegerJaeger Medical GmbHBTY2025-07-23
14250892907595JaegerJaeger Medical GmbHBTY2025-07-23
14250892907601JaegerJaeger Medical GmbHBTY2025-07-23
14250892907656JaegerJaeger Medical GmbHBTY2025-07-23