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510(k) Data Aggregation
K Number
K130379Device Name
ROLLINS 7 OXYGEN MASK
Manufacturer
Date Cleared
2013-10-09
(237 days)
Product Code
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
ROLLINS MEDICAL SOLUTIONS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rollins 7 Oxygen Mask is placed over the nose and mouth to administer oxygen and aerosol therapy via nebulizer only. The Rollins7 Oxygen Mask is for adult use only.
Device Description
The Rollins 7 Oxygen Mask consists of the following features: 1) mask, 2) strap holes, 3) swivel, 4) oxygen inlet, 5)oxygen inlet cap, 6) oxygen outlet diverter, 7) adapter body, 8) fenestration opening slits on both sides of the mask, 9) opening at the chin area, 10) MDI (metered dose inhaler) port hole inlet and insert locks in place, 11) adapter inlet bottom cap, 12) nebulizer inlet, 13) oxygen tubing, 14) oxygen mask inlet for connecting the adapter, and 15) design nipples (left and right) 16) oxygen tubing with one end universal connector and the other end standard oxygen connector 17) oxygen flow rate to FiO2 label attached to universal connector end.
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