Search Results
Found 2 results
510(k) Data Aggregation
K Number
K014174Device Name
HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33
Manufacturer
Date Cleared
2002-02-22
(64 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
BARNSTEAD/THERMOLYNE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Harvey® PV Dry is a prevacuum and post vacuum drying sterilizer intended to provide sterilization of wrapped or unwrapped medical instruments, surgical devices and other heat stable devices in pouches, surgical packs, dental handpieces, instruments, surgical devices and outer water is required for operation of the Harvey® PV Dry.
The sterilizer has four standard cycles: Unwrapped Instruments (135C for 3 minutes); Wrapped Instruments (121C for 30 minute); Special, for dental handpieces (5 minutes (155c for 11ve manator), I 2015 (15) 10 11 (15 ) 10 routine testing of the steam penetration capability into packs. The parameters are fixed for each cycle.
Device Description
The Harvey® PV Dry is a pre/post-vacuum table top steam sterilizer. Its enclosure is made of plastic. The outside dimensions are 15.5"Hx19"Wx23"D, it weighs 115lbs and the chamber is 10" in diameter. The chamber is made from stainless steel at 45 it weighs 11910s and the enamour is 10 - an Mechanical Engineers (ASME) Pressure Vessel Code.
Ask a Question
Ask a specific question about this device
K Number
K953938Device Name
STERILEMAX
Manufacturer
Date Cleared
1997-01-30
(528 days)
Product Code
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
BARNSTEAD/THERMOLYNE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The "Sterilemax" provides sterilization of standard loads of medical and dental instruments, as do the predicate units.
Device Description
The B/T "Sterilemax" is a table top steam sterilizer. As in the case of the predicate units, the Sterilemax has a water reservoir, a heat source and a sealed chamber. The unit is designed with four standard cycles and one optional cycle. The standard cycles are: wrapped instruments (10 min at 135 C.), unwrapped instruments (3 min at 135 C), packs (30 minutes at 121 C.), the optional cycle for dental handpieces (10 min at 132 C.) and liquids for non-clinical applications (15 min at 121 C.). The chamber is constructed of stainless steel with a cast aluminum door and a silicone sealing gasket. The pressure chamber and components are designed, tested and stamped for conformance to ASME code. A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the process per the programmed parameters. The unit has an 80 character alpha-numeric display. This display provides program and process information to the user, as well as fault condition messages. The display also provides the user with instructions regarding device operation. The unit meets the requirements of UL/CUL3101-1, IEC 1010-1-92 safety standards. The unit is designed with additional user safety features such as, door interlocks and over temperature controls. The chamber is 12″ diameter by 18″ deep.
Ask a Question
Ask a specific question about this device
Page 1 of 1