{"publicDeviceRecordKey":"07e537ee-e4bf-41b9-b57d-d09d91fb8ae9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-08-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"30817522012294","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10817522012292","pkgQuantity":200,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"case"},{"deviceId":"10817522012292","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"20817522012299","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10817522012292","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"box"}]},"brandName":"Ameritus ENFit","versionModelNumber":"ENF-80P-40","catalogNumber":"ENF-80P-40","dunsNumber":"066175613","companyName":"KENTEC MEDICAL, INC.","deviceCount":1,"deviceDescription":"8fr 40cm single port feeding tube with ENFit connector","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":"949-863-0810","phoneExtension":null,"email":"kjrooks@kentecmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K100526","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38561","gmdnPTName":"Nasogastric/orogastric tube","gmdnPTDefinition":"A sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FPD","productCodeName":"Tube, Feeding"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}