Medicom® AssureCheck™
Medicom AssureCheck 10HR Steam Biological Indicator
1manufacturer
1catalogue number
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 | AMD Medicom Inc., Canada |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K093794 |
| Record published | 2024-10-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| ST1010 | 25 | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Getinge USA, Inc. | 510(k) number | 2013-08-02 | Class II | Other | AccuFast Biological Indicator Lot SR-430 may have been exposed to conditions affecting its viability. This could result in a false negative (or pass) when exposed to sub-lethal sterilization parameters. | Catalog # 61301606636: 78 Packs (3900 BIs); Catalog # 613016 | 2017-02-23 |
| Mesa Laboratories Bozeman Manufacturing Facility (Zoot) | 510(k) number | 2013-06-04 | Class II | Nonconforming Material/Component | Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. | 2447/100 count boxes | 2013-11-22 |
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.