{"publicDeviceRecordKey":"47e5d5e5-e54e-4b26-b964-ff14c2610121","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-08-11T00:00:00.000Z","devicePublishDate":"2016-09-17T00:00:00.000Z","deviceCommDistributionEndDate":"2025-08-08T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00732094046847","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Welch Allyn, Inc.","versionModelNumber":"901051","catalogNumber":"SPIRO-NS","dunsNumber":"198227881","companyName":"WELCH ALLYN, INC.","deviceCount":1,"deviceDescription":"Welch Allyn SpiroPerfect Spirometry Module includes SpiroPerfect Sensor, Pressure Tubing, Flow Transducers (Qty. 8), Training Posters (Qty. 2), and CardioPerfect Workstation Software","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(315)685-2834","phoneExtension":null,"email":"gdsn_support@MyHillRom.onmicrosoft.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16231","gmdnPTName":"Electrocardiograph, professional, multichannel","gmdnPTDefinition":"A device intended to be used by a healthcare professional in a clinical setting to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It is designed for recording the electrical signal from two or more configurations of electrodes (ECG-leads) at a time (multichannel) and may be intended for resting ECG and/or stress/exercise ECG. It will either include an integrated display or be designed to transmit ECG data to an off-the-shelf device for display; ECG electrodes may be included. Data interpretation and/or telemetry features might also be included.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BZG","productCodeName":"SPIROMETER, DIAGNOSTIC"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}