{"publicDeviceRecordKey":"9f60eb13-429c-4543-895a-8f3babf9d7e0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-12-12T00:00:00.000Z","devicePublishDate":"2018-08-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10891237001161","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00891237001164","pkgQuantity":200,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Outer Case"},{"deviceId":"00891237001164","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Easy Comfort Twist Top Lancets 30G","versionModelNumber":"1164","catalogNumber":null,"dunsNumber":"783518983","companyName":"HOME AIDE DIAGNOSTICS, INC.","deviceCount":1,"deviceDescription":"•  30 Gauge\n•  Twist top lancets\n•  Single use\n•  Provides virtually painless testing\n•  Comfort depth penetration\n•  Smooth tri-bevel point\n•  100 sterile tip lancets per box","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"18009150116","phoneExtension":null,"email":"info@homeaide.us"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61578","gmdnPTName":"Manual blood lancing device, single-use","gmdnPTDefinition":"A sterile, hand-held manual instrument intended to be used for controlled skin puncture/cut to obtain a capillary blood specimen, performed by a healthcare provider (e.g., on a neonate) or a patient (e.g., a diabetic), typically at the fingertip or ear lobe. It includes a preloaded lancet tip, and has a manually-powered mechanism (e.g., spring-loaded) which enables the tip to puncture to a predetermined depth and blood subsequently to be squeezed out of the puncture site. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FMK","productCodeName":"Lancet, Blood"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"30"},"sizeText":null,"sizeString":"Needle Gauge: 30 Gauge"}]},"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":[]}}