Primus Steam Sterilizer
The PRIMUS PSS11-HA and PSS11-HB are healthcare steam sterilisers for surgery, central sterile departments and surgery centres. They sterilise porous and non-porous materials that can…
The PRIMUS PSS11-HA and PSS11-HB are healthcare steam sterilisers for surgery, central sterile departments and surgery centres. They sterilise porous and non-porous materials that can withstand the required heat, moisture and operating temperature.
Pressurised steam acts within a stainless-steel chamber surrounded by a welded jacket. A steam baffle and the chamber-jacket arrangement distribute heat within the vessel. The units offer eleven factory-programmed cycles for the validated load configurations.
Listed Item
PRIMUS Steam Sterilizer ,Healthcare (Model PSS11-HA)
Load Conditions
Cycle selection depends on the material and load being processed. Items that cannot withstand the operating temperature must not be sterilised in these units. The steriliser is mounted on a height-adjustable steel floor stand.
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) | K233132 |
| Record published | 2024-05-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PSS11-HA | In distribution | |
| PSS11-HB | 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.