Exactamix
EXACTAMIX Cap - Large Bore, Internal Thread
86manufacturers in China registered for this device type
3catalogue numbers in this listing
10recalls on this code
Who Else Makes It
Concentrated in Zhejiang (22), Guangdong (22), Jiangsu (11). 18 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| Tung Hing Plastic & Metal(Shenzhen) Co., Ltd. | Longgang Dist, Shenzhen | Guangdong | Contract manufacturer | 15 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
Showing 12 of 86. All 86 manufacturers in China registered for Dispenser, Liquid Medication
Record
| Listed by | Baxter Healthcare Corporation, United States |
|---|---|
| FDA product code | KYX |
| Device type | Dispenser, Liquid Medication |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6430 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-04-08 |
| Record revised | 2020-11-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H9384858 | In distribution | |
| H938711008 | In distribution | |
| H938711006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Doselogix | Team Technologies, Inc. | 120 |
| PreciseDose Dispenser | Medisca Inc. | 96 |
| Health Care Logistics, Inc® | Health Care Logistics, Inc. | 73 |
| MD Ophthalmic Dropper Bottles | Medisca Inc. | 64 |
| Neomed* | Avanos Medical, Inc. | 50 |
| Syringe with Tip Cap (For Oral/Topical Use) | Medisca Inc. | 40 |
| KwikDose Oral Dispenser | Medsafety Solutions LLC | 30 |
| NeoMed Oral Syringe | Neomed Co., Ltd. | 28 |
| DeRoyal | Deroyal Industries, Inc. | 26 |
| Enteral | Gbuk Group Limited | 26 |
| Nutri-LOK | Utah Medical Products, Inc. | 22 |
| CareTip | Gbuk Group Limited | 19 |
Showing 12 of 185. All products under Dispenser, Liquid Medication
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-03-20 | Class II | Under Investigation by firm | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. | 91,100 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 10140 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 168390 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 24,320 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 602340 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 9700 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 63190 units | |
| 2022-07-22 | Class II | Under Investigation by firm | There is a potential of the packaging not maintaining a sterile barrier for the tip caps. | 8500 units | |
| 2022-02-25 | Class II | Mixed-up of materials/components | Product is mislabeled as self-righting Luer slip tip caps, yellow. | 5,500 DISCPACs (100/DISCPAC). | 2026-03-02 |
| 2019-06-27 | Class III | Under Investigation by firm | EXACTAMED 5 mL Oral Dispenser Pharmacy Packs may contain both 5 mL and 10 mL oral dispensers. | 2192000 syringes | 2020-11-02 |
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.