Avanos
H9386105EN ENFit Bax Adapta Cap Size E
86manufacturers in China registered for this device type
5catalogue numbers in this listing
3recalls 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 | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | KYX |
| Device type | Dispenser, Liquid Medication |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6430 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-05-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H9386104EN | 25 | In distribution | |
| H9386105EN | 25 | In distribution | |
| H9386102EN | 25 | In distribution | |
| H9386103EN | 25 | In distribution | |
| H9386109EN | 25 | 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
3 of these are Class III. 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 |
|---|---|---|---|---|
| 2024-03-04 | Class III | Under Investigation by firm | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. | 14,102 cases (6,340,900 units) |
| 2024-03-04 | Class III | Under Investigation by firm | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. | 27,664 cases (12,155,300 units) |
| 2024-03-04 | Class III | Under Investigation by firm | The expiration date was not printed on the outer shipping label, leading to expired syringes being shipped to customers. | 37,476 cases (16,704,600 units) |
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.