{"publicDeviceRecordKey":"e56623f1-1c03-4bec-84e0-30c4c9509076","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-02-10T00:00:00.000Z","devicePublishDate":"2023-11-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00848253003115","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"InHealth Technologies; Blom-Singer®","versionModelNumber":"TP 2208-LEF","catalogNumber":null,"dunsNumber":"120981337","companyName":"Freudenberg Medical, LLC","deviceCount":1,"deviceDescription":"Blom-Singer® FirstFit Surgical Kit with 22.5Fr Voice Prosthesis, 8mm length","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"800-477-5969","phoneExtension":null,"email":"info@inhealth.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36071","gmdnPTName":"Tracheostomy tube speech valve","gmdnPTDefinition":"A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"65394","gmdnPTName":"Tracheoesophageal speech valve guidewire","gmdnPTDefinition":"A hand-held flexible wire intended to assist surgical placement of an indwelling tracheoesophageal speech valve into a tracheoesophageal fistula (puncture). It incorporates a distal connector onto which the speech valve is attached prior to guidewire advancement through a tracheostoma or endoscope; it may in addition be used for the transoral removal of a tracheoesophageal speech valve before introducing its replacement. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EWL","productCodeName":"Prosthesis, Laryngeal (Taub)"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}