Search Results
Found 1 results
510(k) Data Aggregation
K Number
K012716Device Name
MAINSTREAM WATER PURIFICATION DEVICE
Manufacturer
PRISMEDICAL CORP.
Date Cleared
2002-05-07
(265 days)
Product Code
NHV
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
PRISMEDICAL CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To produce from EPA-grade drinking water, sterile purified water to be used within 24-hours of collection that is suitable for:
- cleaning and rinsing open wounds; .
- infection control (cleaning equipment used in . medical procedures, medical personnel's hands);
- use as a diluent for enteral, nutritional, oral . vaccine or oral drug preparations; and
- all other uses of sterile purified water the . practitioner, or clinician deems necessary.
- Not for parenteral administration. .
Device Description
PrISMedical's MainStream™ Water Purification Device (WPD) is a single-use device that will take approximately 3000 mL of drinking water (EPA-grade or equivalent) and remove:
- particulates
- dissolved solids
- organics and inorganics
- microbial contaminants
- endotoxins
to produce water that meets the quality attributes of USP sterile purified water. This device comes in a 260-mL size to provide up to 3-liters of Sterile Purified Water, USP.
The device incorporates several complementary processes:
- Prefiltration .
- Depth filtration .
- Deionization .
- Sterilizing membrane filtration ●
Ask a Question
Page 1 of 1