{"publicDeviceRecordKey":"2f448261-db7e-4a9f-ac16-df1d1cc24b08","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":7,"publicVersionDate":"2025-05-02T00:00:00.000Z","devicePublishDate":"2016-07-15T00:00:00.000Z","deviceCommDistributionEndDate":"2025-04-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00840682118910","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NA","versionModelNumber":"2059291-001","catalogNumber":null,"dunsNumber":"784985108","companyName":"GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.","deviceCount":1,"deviceDescription":"Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)558-5120","phoneExtension":null,"email":"xx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K120125","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"42398","gmdnPTName":"Blood pressure cuff inflator, manual","gmdnPTDefinition":"A bulb-like device intended to be used to manually inflate the cuff of a manual sphygmomanometer. It is connected to one of the connectors of the cuff and the operator manually pumps air into the cuff by continually squeezing this device until the desired pressure within the cuff has been reached. It will typically consist of a rubber bulb, a one-way valve that draws in ambient air, and a release valve used by the operator to slowly release the pressure in the complete sphygmomanometer/cuff/inflator system so that blood pressure can be measured. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"},{"gmdnCode":"34978","gmdnPTName":"Blood pressure cuff, reusable","gmdnPTDefinition":"A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DXQ","productCodeName":"blood pressure cuff"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"55"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-20"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"95"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"15"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}