Puritan Opti-Swab
Puritan Opti-Swab Media Transport System - Sterile Elongated Flock Swab 1ml Amies Medium
3manufacturers in China registered for this device type
3catalogue 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 | Puritan Medical Products Company LLC, United States |
|---|---|
| FDA product code | LIO |
| Device type | Device, Specimen Collection |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2022-12-08 |
| Record revised | 2026-07-24 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -2 to 25 °C |
| Packaging | Case of 6 |
| Distribution end date | 2026-07-23 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LA-117 (3317-H) | 50 | Withdrawn | |
| LA-106 (3506-H) | 50 | Withdrawn | |
| LA-116 (3316-H) | 50 | Withdrawn |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 |
| Sigma Transwab | Medical Wire & Equipment Company (Bath), Ltd. | 11 |
| 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 |
| Caplugs/Evergreen | Caplugs, Inc. | 2 |
Showing 12 of 35. All products under Device, Specimen Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131630 | 2013-10-21 |
| K120846 | 2012-06-08 |
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.