Primus Sterlizer
The PRIMUS PSS11-HC sterilizer uses pressurized steam to process heat and moisture stable medical materials in surgical and central sterile departments. Its validated uses include porous…
The PRIMUS PSS11-HC sterilizer uses pressurized steam to process heat and moisture stable medical materials in surgical and central sterile departments. Its validated uses include porous and nonporous loads. Materials must withstand the selected cycle’s operating temperature and moisture conditions.
A stainless steel chamber and surrounding jacket form the sterilizer vessel. Steam enters the chamber through a baffled inlet, while the drainage system removes condensate. A vacuum system reduces chamber pressure during conditioning and drying, and filtered air restores atmospheric pressure after the drying phase.
Listed Item
PRIMUS Healthcare Sterilizer (Model PSS11-HC)
Cycle Control
A touchscreen provides access to programmed processing cycles and operating controls. The integrated thermal printer records cycle data at the start, at transitions and at completion, providing a paper record of the run. Cycle and load selection must follow the validated configurations.
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Primus Sterilizer Company, LLC., United States |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Manufacturer |
| 510(k) | K221474 |
| Record published | 2023-12-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSS11-HC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Sterilizer, Steam | Steris Mexico, S. de R.L. de C.V. | 53 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Primus Sterilizer | Primus Sterilizer Company, LLC. | 24 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
Showing 12 of 119. All products under Sterilizer, Steam
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233132 | 2023-12-19 |
| K221474 | 2023-02-10 |
| K093333 | 2010-04-02 |
| K082817 | 2009-05-21 |
| K991575 | 1999-12-03 |
| K926185 | 1994-05-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.