Sigma Transwab
Sigma Transwab (fecal), Screw Vial, Green cap 2ml Cary Blair, Plastic Foam
3manufacturers in China registered for this device type
11catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Sterigenics Shanghai E Beam Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
Record
| Listed by | Medical Wire & Equipment Company (Bath), Ltd., United Kingdom |
|---|---|
| FDA product code | LIO |
| Device type | Device, Specimen Collection |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2900 |
| Record published | 2023-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 25 °C |
| Distribution end date | 2023-10-05 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Sigma Transwab | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | In distribution | |
| Amies | 125 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Remel | Remel, Inc. | 21 |
| Sigma Virocult | Medical Wire & Equipment Company (Bath), Ltd. | 16 |
| Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 14 |
| Puritan UniTranz-RT | Puritan Medical Products Company LLC | 13 |
| Starswab II Bacteriology Culture Collection and Transport System | Pretium Canada Packaging ULC | 10 |
| Vacuette | Greiner BIO-ONE Gmbh | 4 |
| Bacti-Swab | Remel, Inc. | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 4 |
| Puritan | Puritan Medical Products Company LLC | 4 |
| Covidien | Cardinal Health 200, LLC | 3 |
| Puritan Opti-Swab | Puritan Medical Products Company LLC | 3 |
| Caplugs/Evergreen | Caplugs, Inc. | 2 |
Showing 12 of 35. All products under Device, Specimen Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103805 | 2011-01-25 |
| K082472 | 2008-12-30 |
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.