{"publicDeviceRecordKey":"e5fe9e48-52fb-4c32-8fd1-3df698254b4e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2026-02-02T00:00:00.000Z","devicePublishDate":"2025-11-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"30889483563247","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10889483563243","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"10889483563243","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00609038938820","deviceIdType":"Previous","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00889483563246","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"BALLARD™","versionModelNumber":"1222","catalogNumber":"1222","dunsNumber":"069009268","companyName":"SUNMED, LLC","deviceCount":5,"deviceDescription":"BALLARD™ ORAL CARE SUCTION CATHETER FOR NEONATES/PEDIATRICS","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1-800-433-2797","phoneExtension":null,"email":"info@sun-med.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"10749","gmdnPTName":"Airway suction catheter","gmdnPTDefinition":"A flexible tube designed to be inserted through the mouth, artificial airway, tracheostomy tube, and/or nostrils, for periodic aspiration of liquids and/or semi-solids from a patient's airway (e.g., pharynx, trachea, bronchi, nasal cavity) as part of a suction system; it is not intended to inflate the lungs. It is typically made of polymer with a smooth and rounded distal-tip, often including end and side holes and a finger-controlled valve to regulate suction. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JOL","productCodeName":"Catheter And Tip, Suction"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"8"},"sizeText":null,"sizeString":"Catheter Gauge: 8 French"}]},"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":[]}}