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510(k) Data Aggregation
K Number
K242717Device Name
Laboratorios Biogalenic Sterile Water for Inhalation, USP
Manufacturer
Laboratorios Biogalenic, S.A. DE C.V.
Date Cleared
2025-01-30
(142 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
Laboratorios Biogalenic, S.A. DE C.V.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.
Device Description
Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:
- A 36 mm PP screw cap with a PP/PET aluminium induction seal .
- A 28mm bromobutyl stopper with an aluminium seal .
The bottles are available in the following volume configurations:
- . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
- 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.
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