FDA.reportPublic FDA data

SpiroSphere

Primary DI
04057155000757
Brand
SpiroSphere
Company
eResearchTechnology GmbH
Model
SpiroSphere
Device description
Diagnostic spirometer for measurement and data collection of lung function parameters
Published
2021-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
04057155000757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057155000757040571550007574057155000757

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic spirometerAn electrically-powered device designed to measure several or all respiratory-gas volume and flow parameters needed to evaluate basic pulmonary function [e.g., vital capacity (VC), peak expiratory flow (PEF), forced expiratory volume (FEV), and forced expiratory flow (FEF)]. It is an instrument used in a clinical setting with a mouthpiece and tube attached to a computerized unit to process the data from patient ventilatory efforts, volume and/or flow sensors, a display, and usually a graph recorder. The data are compared to standardized values or the patient's former values to help identify or evaluate chronic pulmonary disorders such as asthma, emphysema, or bronchitis.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1800 7049698CustomerCare@ert.com
+1 908 5952020CustomerCare@clario.com
+4993057209891CustomerCare@clario.com

Regulatory Flags#

DUNS number
341625331
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04057155000948ERT PTERT PT2025-08-11
04057155000955ERT 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
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
04057155000955ERT 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