{"publicDeviceRecordKey":"6c211394-feb6-4225-ac5d-332e3b895f5d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2025-04-04T00:00:00.000Z","devicePublishDate":"2016-09-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20818392014796","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10818392014799","pkgQuantity":8,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"10818392014799","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00818392014792","pkgQuantity":100,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00818392014792","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SOL-CARE™ Luer Lock Safety Syringe with Exchangeable Needle","versionModelNumber":"100079IM","catalogNumber":null,"dunsNumber":"069590113","companyName":"Sol-Millennium Medical, Inc.","deviceCount":1,"deviceDescription":"Used to inject fluids into, or withdraw fluids from the body. In addition, the device is designed to aid in the prevention of needle stick injuries.","DMExempt":false,"premarketExempt":false,"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":true,"otc":false,"contacts":{"customerContact":[{"phone":"833-637-0857","phoneExtension":null,"email":"info@solm.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45042","gmdnPTName":"Metered-delivery hypodermic syringe/needle","gmdnPTDefinition":"A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MEG","productCodeName":"SYRINGE, ANTISTICK"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"25"},"sizeText":null,"sizeString":"Length: 25 Millimeter"},{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"25"},"sizeText":null,"sizeString":"Needle Gauge: 25 Gauge"},{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"3"},"sizeText":null,"sizeString":"Total Volume: 3 Milliliter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}