Puritan HydraFlock
Puritan® HydraFlock® Sterile Flocked Collection Devices
100manufacturers in China registered for this device type
39catalogue numbers in this listing
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 | 2022-12-08 |
| Record revised | 2026-07-23 (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, manufacturing date |
| Packaging | Case of 10, box of 50, box of 100, case of 5, case – 50 sheetsx20 of 1000, box of 24 |
| Distribution end date | 2026-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-3000-H E30 | In distribution | |
| 25-3319-H | In distribution | |
| 25-3317-U 20 | In distribution | |
| 25-3318-H | In distribution | |
| 25-3317-H BT | In distribution | |
| 25-3316-H 1217501 | In distribution | |
| 25-3206-H 20MM BT | In distribution | |
| 25-3306-H BT US | In distribution | |
| 25-3606-H BT | In distribution | |
| 25-3406-H | In distribution | |
| 25-3318-H BT | In distribution | |
| 25-3206-H EMB 33MM PHX | In distribution | |
| 25-3306-H | In distribution | |
| 25-3606-H | In distribution | |
| 25-3320-H | In distribution | |
| 25-3706-H BT | In distribution | |
| 25-3806-H BT | In distribution | |
| 25-3317-H | In distribution | |
| 25-3206 2H | In distribution | |
| 25-3316-H EMB 79.5MM | In distribution | |
| 25-3206-H 20MM | In distribution | |
| 25-3319-H BT | In distribution | |
| 25-3316-H EMB 100 BT | In distribution | |
| 25-3000-U E30 | In distribution | |
| 25-3316-H EMB 80 BT | In distribution | |
| 25-3706-H | In distribution | |
| 25-3206-H | In distribution | |
| 25-3506-H | In distribution | |
| 25-3806-H BT PK | In distribution | |
| 25-3320-H EMB 80MM | In distribution | |
| 25-3316-H | In distribution | |
| 25-3320-H EMB 100MM | In distribution | |
| 25-3806-H | In distribution | |
| 25-3406-H BT | In distribution | |
| 25-3706-H BT PK | In distribution | |
| 25-3206-H EMB 50MM PRT | Withdrawn | |
| 25-3316-H 60MM PRT | Withdrawn | |
| 25-3206-H EMB 50MM | Withdrawn | |
| 25-3306-H 100/13 | Withdrawn |
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 |
| 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 |
| CLASSIQSwabs™ | Copan Italia | 22 |
Showing 12 of 134. All products under Applicator, Absorbent Tipped, Sterile
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Puritan Medical Products Company LLC | UDI-DI | 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 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 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.