Panels › General Hospital › Product code OJA · Class 2
Intravenous Extension Tubing Set
Regulation 880.5440
0510(k)s in 12 months (1 all time)
1recalls in 12 months (4 all time)
0recalls that name a 510(k)
Top companies in OJA
| Company | 510(k)s | Recalls |
|---|---|---|
| Merit Medical Systems, Inc. | 0 | 3 |
| Cardinal Health 200, LLC | 0 | 1 |
| Life-Tech Intl., Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2026 | Cardinal Health 200, LLC Cardinal Health Presource Kits:
1) SEPTO RHINO PACK , Catalog Number: SEN73NSKCF;
2) PACK NEURO MINOR CRANIOTOMY , Catalog Number: SNE30CNOHE;
3) NEURO MAJOR 2 PACK , Catal Open, Classified |
OJA | None listed |
| Aug 12, 2025 | Merit Medical Systems, Inc. Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029 Open, Classified |
OJA | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K08-PI (Custom Fluid Management Kit), REF:
K08-02042
K08-02948
K08-03026
K08-03119
A Open, Classified |
OJA | None listed |
| Aug 12, 2024 | Merit Medical Systems, Inc. Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes:
K04 (Custom Syringe Kit), REF:K04-00791A
An intravascular administration set is a de Open, Classified |
OJA | None listed |
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