{"publicDeviceRecordKey":"659d901b-b327-4a57-81ab-1e7984ffe247","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2015-05-05T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B00287551","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B00287550","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case of 6"},{"deviceId":"B00287550","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Rescuer Emergency CPAP System","versionModelNumber":"8755","catalogNumber":"8755","dunsNumber":"200103823","companyName":"B.L.S. Systems Limited","deviceCount":1,"deviceDescription":"Rescuer Emergency CPAP System with #4 Cushion Mask and silicone head strap used for patients exhibiting acute episodes of respiratory distress.","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"905 3391069","phoneExtension":null,"email":"tedreesor@blssystemsltd.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K122610","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"57813","gmdnPTName":"CPAP/BPAP face mask, single-use","gmdnPTDefinition":"A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"BYE","productCodeName":"Attachment, Breathing, Positive End Expiratory Pressure"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"#4 Cushion Mask"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"60"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-40"},"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}