{"publicDeviceRecordKey":"b43d15f1-22da-475f-8eb9-8cc44c3b9e37","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2022-08-30T00:00:00.000Z","devicePublishDate":"2015-09-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EBES50402N1","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"EBES50402N0","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton"},{"deviceId":"EBES50402N0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Doyle Ear Dressing","versionModelNumber":"50-402N","catalogNumber":"50-402N","dunsNumber":"131855157","companyName":"Boston Medical Products, Inc.","deviceCount":1,"deviceDescription":"Size: Pediatric; Color: Natural","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-433-2674","phoneExtension":null,"email":"info@bosmed.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46855","gmdnPTName":"Wound-nonadherent dressing, permeable, non-antimicrobial","gmdnPTDefinition":"A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NAD","productCodeName":"Dressing,Wound,Occlusive"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Size: Pediatric"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep dry"},{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep away from sunlight"}]},"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":[]}}