Jiangsu Caina Medical Co., Ltd · 89-08 · CHINA
For Jiangsu Caina Medical Co., Ltd, import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is Safety Push Button Blood Collection Set | O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | Syringes; With or without Needles | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Disposable Insulin Syringe | Safelock Disposable Insulin Syringe | Hard pack syringe | Syringes; With or without Needles | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Safety Insulin Pen Needle | Disposable Insulin Pen Needle | Disposable Insulin Syringe | Hard pack syringe | Safelock Disposable Blood Collection Set; Disposable Blood Collection Set | Safety Push Button Blood Collection Set | Disposable Infusion Needle; Safelock Disposable Infusion Needle | Vented Vial Transfer Pin | Safelock Disposable Insulin Syringe | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Pre filled Syringe with Saline; product code is 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection | 78 P - - NR Enteral Syringes with enteral specific connectors | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 L - - HI Set, I.V. Fluid Transer | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 N - - GT Device, Flush, Vascular Access; date published is 05/08/2026; address is No. 23 Huanxi Road , Zhutangzhen Jiangyin , Wuxi, Jiangsu CHINA, verified against its source on 2026-09-30.
- Firm
- Jiangsu Caina Medical Co., Ltd verified
- Import alert
- 89-08
- Import alert name
- "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- Country
- CHINA verified
- Address
- No. 23 Huanxi Road , Zhutangzhen Jiangyin , Wuxi, Jiangsu CHINA verified
- Date published
- 05/08/2026 verified
- Product code
- 75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection | 78 P - - NR Enteral Syringes with enteral specific connectors | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 F - - PA Set, Administration, Intravascular | 80 L - - HI Set, I.V. Fluid Transer | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 N - - GT Device, Flush, Vascular Access each item verified
- Product
- Safety Push Button Blood Collection Set | O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | Syringes; With or without Needles | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Disposable Insulin Syringe | Safelock Disposable Insulin Syringe | Hard pack syringe | Syringes; With or without Needles | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Safety Insulin Pen Needle | Disposable Insulin Pen Needle | Disposable Insulin Syringe | Hard pack syringe | Safelock Disposable Blood Collection Set; Disposable Blood Collection Set | Safety Push Button Blood Collection Set | Disposable Infusion Needle; Safelock Disposable Infusion Needle | Vented Vial Transfer Pin | Safelock Disposable Insulin Syringe | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Pre filled Syringe with Saline each item verified
- FDA notes
- Safety Push Button Blood Collection Set | O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) | Syringes; With or without Needles | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Disposable Insulin Syringe | Safelock Disposable Insulin Syringe | Hard pack syringe >>declaring K141359 | Syringes; With or without Needles | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Safety Insulin Pen Needle | Disposable Insulin Pen Needle | Disposable Insulin Syringe | Hard pack syringe >>declaring K141359 | Safelock Disposable Blood Collection Set; Disposable Blood Collection Set | Safety Push Button Blood Collection Set | Disposable Infusion Needle; Safelock Disposable Infusion Needle | Vented Vial Transfer Pin | Safelock Disposable Insulin Syringe | 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle | Pre filled Syringe with Saline each item verified
What the source says
Jiangsu Caina Medical Co., Ltd Date Published : 05/08/2026 No. 23 Huanxi Road , Zhutangzhen Jiangyin , Wuxi, Jiangsu CHINA
— accessdata.fda.gov, retrieved 2026-09-28
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
75 J - - KA Tubes, Vials, Systems, Serum Separators, Blood Collection Date Published: 05/08/2026 Desc: Safety Push Button Blood Collection Set Notes: Safety Push Button Blood Collection Set 78 P - - NR Enteral Syringes with enteral specific connectors Date Published: 05/08/2026 Desc: O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) Notes: O ring gasket syringe with ENFit connector (single use or reusable) Oral/Enteral syringe with ENFit connector (single use or reusable) 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Syringes; With or without Needles Notes: Syringes; With or without Needles 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle Notes: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Disposable Insulin Syringe Notes: Disposable Insulin Syringe 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Safelock Disposable Insulin Syringe Notes: Safelock Disposable Insulin Syringe 80 F - - MF Syringe, Piston Date Published: 05/08/2026 Desc: Hard pack syringe Notes: Hard pack syringe >>declaring K141359<<< 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Syringes; With or without Needles Notes: Syringes; With or without Needles 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle Notes: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Safety Insulin Pen Needle Notes: Safety Insulin Pen Needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Disposable Insulin Pen Needle Notes: Disposable Insulin Pen Needle 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Disposable Insulin Syringe Notes: Disposable Insulin Syringe 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 05/08/2026 Desc: Hard pack syringe Notes: Hard pack syringe >>declaring K141359<<< 80 F - - PA Set, Administration, Intravascular Date Published: 05/08/2026 Desc: Safelock Disposable Blood Collection Set; Disposable Blood Collection Set Notes: Safelock Disposable Blood Collection Set; Disposable Blood Collection Set 80 F - - PA Set, Administration, Intravascular Date Published: 05/08/2026 Desc: Safety Push Button Blood Collection Set Notes: Safety Push Button Blood Collection Set 80 F - - PA Set, Administration, Intravascular Date Published: 05/08/2026 Desc: Disposable Infusion Needle; Safelock Disposable Infusion Needle Notes: Disposable Infusion Needle; Safelock Disposable Infusion Needle 80 L - - HI Set, I.V. Fluid Transer Date Published: 05/08/2026 Desc: Vented Vial Transfer Pin Notes: Vented Vial Transfer Pin 80 M - - EG Syringe, Antistick Date Published: 05/08/2026 Desc: Safelock Disposable Insulin Syringe Notes: Safelock Disposable Insulin Syringe 80 M - - EG Syringe, Antistick Date Published: 05/08/2026 Desc: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle Notes: 1ml Luer Slip or Luer Lock Syringe; Syringe with permanently attached needle; Safety Syringe with permanently attached needle 80 N - - GT Device, Flush, Vascular Access Date Published: 05/08/2026 Desc: Pre filled Syringe with Saline Notes: Pre filled Syringe with Saline
— all from accessdata.fda.gov, retrieved 2026-09-28
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html