Sterizone® VP4 Test Pack Kit
The FDA filing names the STERIZONE VP4 Test Pack and describes its component assembly. The pack contains a self-contained biological indicator, a 10 mL syringe and plunger, and a diffusion…
The FDA filing names the STERIZONE VP4 Test Pack and describes its component assembly.
The pack contains a self-contained biological indicator, a 10 mL syringe and plunger, and a diffusion restrictor; a chemical indicator is added externally to distinguish processed from unprocessed packs.
Listed Item
Description of the test packs kit (TSO3 product code 44020): • Syringe with plunger • Diffusion restrictor
Monitoring Process
After processing, the biological indicator is retrieved to assess spore kill by the STERIZONE VP4 sterilizer. The test pack is placed within the load on the sterilizer loading rack.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Tso3, Inc., Canada |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| 510(k) | K141580 |
| Record published | 2016-09-14 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 44020 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bionova® | Terragene S.A. | 47 |
| Attest™ | 3M Company | 36 |
| Verify | Steris Corporation | 27 |
| 3M™ Attest™ | 3M Company | 16 |
| Celerity | Steris Corporation | 15 |
| Biotrace™ | Terragene S.A. | 11 |
| Single Species BI Strip | Crosstex International | 11 |
| Tuttnauer® | Terragene S.A. | 10 |
| Sterrad Velocity™ | Advanced Sterilization Products Services Inc. | 8 |
| GPS | Group Practice Solutions | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Propper Duo Spore Biological Indicators | Propper Manufacturing Co., Inc. | 7 |
Showing 12 of 173. All products under Indicator, Biological Sterilization Process
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141580 | 2014-12-17 |
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.