{"publicDeviceRecordKey":"d5437b93-32b7-4fd5-b1fe-3878c880ca37","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-11-14T00:00:00.000Z","devicePublishDate":"2022-09-02T00:00:00.000Z","deviceCommDistributionEndDate":"2024-09-23T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"14719882250412","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"04719882250415","pkgQuantity":4,"pkgDiscontinueDate":"2024-09-23","pkgStatus":"Not in Commercial Distribution","pkgType":"Carton"},{"deviceId":"04719882250415","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"04719882250408","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Copioumed","versionModelNumber":"SCN0B101-1","catalogNumber":null,"dunsNumber":"658318113","companyName":"COPIOUMED INTERNATIONAL INC.","deviceCount":150,"deviceDescription":"Copioumed Bouffant Cap provides an ideal headwear for a higher level of protection and comfort. The single-use cap features a latex-free elastic band around its circumference. This helps prevent allergic reactions that are due to exposure to latex . Which offers protection against particles- and hair-related cross-contamination, making it the preferred line for the operating theatre.","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":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+886227721815","phoneExtension":null,"email":"info@gcv.com.tw"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"32297","gmdnPTName":"Surgical cap, single-use","gmdnPTDefinition":"A head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FYF","productCodeName":"Cap, Surgical"}]},"deviceSizes":{"deviceSize":[]},"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,"premarketSubmissions":{"premarketSubmission":[]}}