{"publicDeviceRecordKey":"33b08bda-50a4-4e6d-8f05-ca7cee9de599","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-05-28T00:00:00.000Z","devicePublishDate":"2021-05-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"50840200311514","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10840200311523","pkgQuantity":24,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"10840200311523","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"E.M Adams co, inc.","versionModelNumber":"EP90529XLPB-1","catalogNumber":null,"dunsNumber":"001403807","companyName":"E.M. ADAMS, INC.","deviceCount":1,"deviceDescription":"SAFETY VEST\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(772)461-0532","phoneExtension":null,"email":"EMADAMS@EMADAMSCO.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K971948","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62482","gmdnPTName":"Limb/torso/head restraint, reusable","gmdnPTDefinition":"A non-rigid device, typically a strap(s) or band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FMQ","productCodeName":"Restraint, Protective"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"X LARGE VEST/1.5\" X 144\" STRAP/1.5\" X 21\" STRAP"}]},"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}