{"publicDeviceRecordKey":"15b098d1-ff29-427c-9ba5-0814ccb9aa85","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2021-09-15T00:00:00.000Z","devicePublishDate":"2020-04-14T00:00:00.000Z","deviceCommDistributionEndDate":"2021-01-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00856446007000","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"10856446007007","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Disposable Troop Elevation Pillow","versionModelNumber":"10-910-00","catalogNumber":"10-910-00","dunsNumber":"006375677","companyName":"CR ENTERPRISES, LLC","deviceCount":4,"deviceDescription":"Disposable barrier covered Troop Elevation Pillow - 4 per box","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"972-625-5177","phoneExtension":null,"email":"rtroop@tx.rr.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62292","gmdnPTName":"Freestanding patient positioner, single-use","gmdnPTDefinition":"A preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"CCX","productCodeName":"Support, Patient Position"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"30"},"sizeText":null,"sizeString":"Length: 30 Inch"},{"sizeType":"Width","size":{"unit":"Inch","value":"20"},"sizeText":null,"sizeString":"Width: 20 Inch"},{"sizeType":"Height","size":{"unit":"Inch","value":"5.75"},"sizeText":null,"sizeString":"Height: 5.75 Inch"}]},"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":[]}}