QuidelOrtho
QuidelOrtho Specimen Collection Swab
100manufacturers in China registered for this device type
1catalogue number
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (24), Zhejiang (20), Guangdong (12). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Bandex Industrial Corp. | Zhuhai | Guangdong | Contract manufacturer | 14 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Anqing Jiaxin Medical Technology Co., Ltd. | Anqing | Anhui | Contract manufacturer | 11 |
| Yancheng Huida Medical Instruments Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 10 |
| Changzhou Hongtai Paper Film Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
Showing 12 of 100. All 100 manufacturers in China registered for Applicator, Absorbent Tipped, Sterile
Record
| Listed by | Puritan Medical Products Company LLC, United States |
|---|---|
| FDA product code | KXG |
| Device type | Applicator, Absorbent Tipped, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6025 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-1000 1PD BT 340-090T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HanHeng | Jiangsu Hanheng Medical Technology Co., Ltd. | 188 |
| Custom Healthcare Systems Inc. | Manus Medical, LLC | 70 |
| Puritan | Puritan Medical Products Company LLC | 68 |
| FLOQSwabs® | Copan Italia | 54 |
| Puritan HydraFlock | Puritan Medical Products Company LLC | 39 |
| Specimen Collection Swab | HLB Co., Ltd. Healthcare | 38 |
| DeRoyal | Deroyal Industries, Inc. | 31 |
| Puritan PurFlock Ultra | Puritan Medical Products Company LLC | 29 |
| iClean | Huachenyang(Shenzhen)Technology Co., Ltd. | 28 |
| DHI Specimen Collection System | Diagnostic Hybrids, Inc. | 27 |
| National Hospital Packaging | Surgi-Pak, Inc. | 27 |
| Dryswab | Medical Wire & Equipment Company (Bath), Ltd. | 26 |
Showing 12 of 134. All products under Applicator, Absorbent Tipped, Sterile
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-02-21 | Class II | Process control | It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages. | 465 boxes x 500 units per box = 232,500 units | |
| 2014-12-22 | Class II | Process control | Shaft breaks so that adequate patient specimen sample cannot be obtained. | 9 cases of 500 applicators each | 2015-03-18 |
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.