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510(k) Data Aggregation
K Number
K991575Device Name
PRIMUS STEAM STERILIZERS
Manufacturer
PRIMUS STERILIZER CO., INC.
Date Cleared
1999-12-03
(211 days)
Product Code
FLE, FIF
Regulation Number
880.6880Why did this record match?
Applicant Name (Manufacturer) :
PRIMUS STERILIZER CO., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PRIMUS PSS Series Steam Sterilizers are designed for use in Hospital operating suites, central sterile supply and clinical laboratories. The PRIMUS PSS Series Sterilizes provide efficient steam sterilization of non-porous and porous, heat and moisture stabile materials. The PSS Series Sterilizers are available in the following configurations:
13" x 13" x 23" Multi-Functional Sterilizer Single Door
13" x 13" x 23" Laboratory/Lo Single Door
16" x 16" x 26" Multi-Functional Sterilizer Single or Double Door
16" x 16" x 26" Laboratory/Lo Single or Double Door
20" x 20" x 38" Multi-Functional Sterilizer Single or Double Door
20" x 20" x 38" Laboratory/Lo Single or Double Door
26" x 26" x 39" Multi-Functional Sterilizer Single or Double Door
26" x 26" x 39" Laboratory/Lo Single or Double Door
26" x 26" x 49" Multi-Functional Sterilizer Single or Double Door
26" x 26" x 49" Laboratory/Lo Single or Double Door
26" x 26" x 67" Multi-Functional Sterilizer Single or Double Door
26" x 26" x 67" Laboratory/Lo Single or Double Door
26" x 36" x 39" Multi-Functional Sterilizer Single or Double Door
26" x 36" x 39" Laboratory/Lo Single or Double Door
26" x 36" x 48" Multi-Functional Sterilizer Single or Double Door
26" x 36" x 48" Laboratory/Lo Single or Double Door
26" x 36" x 60" Multi-Functional Sterilizer Single or Double Door
26" x 36" x 60" Laboratory/Lo Single or Double Door
26" x 63" x 48" Multi-Functional Sterilizer Single or Double Door
26" x 63" x 48" Laboratory/Lo Single or Double Door
26" x 63" x 76" Multi-Functional Sterilizer Single or Double Door
26" x 63" x 76" Laboratory/Lo Single or Double Door
Sterilizers are available in Multifunctional models which includes vacuum and gravity cycles and Laboratory/Lo-Temperature models which includes the wacuum and gravity cycles as well as a low temperature feature for pasteurization and inspissation processes.
Device Description
The PRIMUS PSS series steam sterilizers are class II medical devices as defined by 21 CFR 880.6880. The PSS series sterilizers feature fully jacketed, rectangular 316L stainless steel chambers with sliding doors. The units are available in Multifunction or Laboratory/Lo configurations. The Multifunction units offer both prevacuum and gravity configurations, whereas the Laboratory/Lo units offer prevacuum, gravity, and a low operating temperature configuration.
The PRIMUS PSS series sterilizers are offered for sale with the following factory-set sterilization cycles and cycle values:
CYCLES | STERILIZE TEMP | STERILIZE TIME | DRY TIME | RECOMMENDED LOAD
---|---|---|---|---
GRAVITY | 132° C | 4 MINUTES | 1 MINUTE | HARD GOODS
VACUUM | 132° C | 4 MINUTES | 15 MINUTES | WRAPPED GOODS
LIQUIDS | 121° C | 30 MINUTES | *8 MINUTES | LIQUIDS
TEST (VAC) | 132° C | 4 MINUTES | 3 MINUTES | BOWIE-DICK TEST
*Liquid Cycle is Cool Time
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