FDA.reportPublic FDA data

Rotationsflowgeber Set

Primary DI
04057155000320
Brand
Rotationsflowgeber Set
Company
eResearchTechnology GmbH
Model
Rotationsflowgeber Set
Device description
Set of three rotary flow sensors for single-patient use, accessory to Asthma Monitor
Published
2016-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZGSpirometer, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZGSpirometer, DiagnosticAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K090486000
K092890000
K133722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K090486000ASTHMA MONITOR MODEL, AM1Cardinal Health Germany 234 GmbH2009-05-06BZG
K092890000ASTHMA MONITOR AM3Carefusion Germany 234 GmbH2010-01-13BZG
K133722000ASTHMA MONITOR AM3Eresearch Technology2014-05-08BZG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04057155000320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04057155000320040571550003204057155000320

GMDN Terms#

Term, Definition table
TermDefinition
Peak flow meter, electronicA battery-powered, hand-held instrument designed to measure the maximum rate of expiratory gas flow [peak expiratory flow (PEF) or peak expiratory flow rate (PEFR)] and forced expiratory volume (FEV) from the lungs. It typically includes a mouthpiece for patient exhalation and a digital display [e.g., liquid-crystal display (LCD)]; it may include a port for communicating with a personal computer (PC). The device is typically intended to monitor the respiratory status of a patient suffering from chronic respiratory disease (e.g., asthama, emphysema) in a clinical setting or the home.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
341625331
Device count
1
Lot or batch
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
04057155000757SpiroSphereSpiroSphere2021-02-18

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