Passport Plus Mail-IN System
Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
1manufacturer
2catalogue numbers in this listing
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 | SPS Medical Supply Corp. |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Record published | 2016-11-15 |
| Record revised | 2024-01-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Controlled room temperature per USP; Storage environment temperature 20 to 25 °C |
| Packaging | Box of 10, box of 4 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PP-012 | 12 | In distribution | |
| PP-052 | 52 | 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
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.