FDA device listing
Safety Sliding Blood Collection Set, Safety Butterfly Blood Collection Set, Sliding Blood Collection Set
FDA device listing 1801957539 · New Pentastar Medical Products Co. Limited
Key facts
| Proprietary names | Safety Sliding Blood Collection Set, Safety Butterfly Blood Collection Set, Sliding Blood Collection Set |
|---|---|
| Owner/operator | New Pentastar Medical Products Co. Limited |
| Owner/operator number | 10063374 |
| Premarket submissions | K232781 |
| Product codes | JKA |
| Device names | JKA - Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1675 |
| Review panels | Clinical Chemistry |
| Registered establishments | JIANGSU NEW PENTASTAR MEDICAL PRODUCTS CO. LTD. |
| Establishment registrations | 3015058854 |
| FEI numbers | 3015058854 |
| Establishment operations | Foreign Exporter |
| 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