Remel
Cary-Blair w/Ind/SAF/Empty Vial PK/84SET
3manufacturers in China registered for this device type
21catalogue numbers in this listing
5510(k) clearances naming this product code
1recall
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 | Remel, Inc., United States |
|---|---|
| FDA product code | LIO |
| Device type | Device, Specimen Collection |
| Device class | Class 1 |
| Regulation | 21 CFR 866.2900 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K013711 |
| Record published | 2022-12-22 |
| Record revised | 2025-03-12 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-03-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R21927 | In distribution | |
| R21616 | In distribution | |
| R21962 | In distribution | |
| R21765 | In distribution | |
| R21949 | In distribution | |
| R21710 | In distribution | |
| R21943 | In distribution | |
| R21615 | In distribution | |
| R21925 | In distribution | |
| R21278 | In distribution | |
| R21617 | In distribution | |
| R05039 | In distribution | |
| R31610 | In distribution | |
| R31925 | In distribution | |
| R21610 | In distribution | |
| R21924 | In distribution | |
| R21968 | Withdrawn | |
| R31949 | Withdrawn | |
| R31620 | Withdrawn | |
| R05038 | Withdrawn | |
| R21620 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K013711 | 2001-11-26 |
| K981391 | 1998-07-14 |
| K931383 | 1993-06-15 |
| K912832 | 1991-08-22 |
| K912831 | 1991-07-30 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-05-07 | Not classified | Incorrect or no expiration date | Incorrect expiration date on the product | 103 packages | 2010-01-15 |
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.