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510(k) Data Aggregation
K Number
K223551Device Name
Sterile Water for Inhalation in 1L Flexoval ® bottles.
Manufacturer
Hometa Inc
Date Cleared
2023-08-03
(251 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
Hometa Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Water for Inhalation Flexoval® Bottle is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional care settings by qualified staff. The Sterile Water for Inhalation is intented for use in all patient populations including adults, pediatrics, infants and neonates.
Device Description
The Sterile Water for Inhalation is provided in a Flexoval® bottle which is a flexible plastic bottle with a spikeable cap at the base and is pre-filled with sterile water. The bottle is 1 liter in volume and is made of Low-Density Polyethylene (LDPE). The bottle has one administration port (cap) which is clear and natural in color. The bottle has one standard hanger that is integrated at the base of the bottle also has a multi-color adhesive label affixed by an automatic labeler. The product is sterilized by heat in an autoclave. The device is sold sterile and cannot be re-used: it is discarded after use. The device is intended for use by qualified staff.
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