FDA device listing
Blood Collection Needle with/without Holder,Luer Access Device-holder with Preattached Multiple Sample Adapter,PAL…
FDA device listing 2072040510 · Jiangsu Caina Medical Co., Ltd
Key facts
| Proprietary names | Blood Collection Needle with/without Holder,Luer Access Device-holder with Preattached Multiple Sample Adapter,PAL Infiltration Device,Safety Blood Collection Needle with/without Holder |
|---|---|
| Owner/operator | Jiangsu Caina Medical Co., Ltd |
| Owner/operator number | 10038768 |
| Premarket submissions | K200027 |
| Product codes | FMI, JKA, QPB |
| Device names | FMI - Needle, Hypodermic, Single Lumen, JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection, QPB - System, Suction, Lipoplasty For Removal |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675, 878.5040, 880.5570 |
| Review panels | Clinical Chemistry, General Hospital, General & Plastic Surgery |
| Registered establishments | JIANGSU CAINA MEDICAL CO., LTD, ROBLING MEDICAL, LLC |
| Establishment registrations | 3005670221, 3007829657 |
| FEI numbers | 3005670221, 3007829657 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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