FDA device listing
KenFlush KFS1000,One-Care Saline Flush Syringe, Sterile Fluid Path 10ml,One-Care Saline Flush Syringe, Sterile Fluid…
FDA device listing 1438354090 · Hantech Medical Device Co., Ltd.
Key facts
| Proprietary names | KenFlush KFS1000,One-Care Saline Flush Syringe, Sterile Fluid Path 10ml,One-Care Saline Flush Syringe, Sterile Fluid Path 5ml,PRE-FILLED SALINE FLUSH SYRINGE,10ML , ITEM 5079,PRE-FILLED SALINE FLUSH SYRINGE,5ML , ITEM 5078 |
|---|---|
| Owner/operator | Hantech Medical Device Co., Ltd. |
| Owner/operator number | 10058745 |
| Premarket submissions | K231363 |
| Product codes | NGT |
| Device names | NGT - Saline, Vascular Access Flush |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| Registered establishments | HANTECH MEDICAL DEVICE CO., LTD. |
| Establishment registrations | 3015060216 |
| FEI numbers | 3015060216 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database