Data / Medical devices / Spinal Anesthesia Kit
Spinal Anesthesia Kit (OFU): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Spinal Anesthesia Kit (product code OFU, Class 2, 21 CFR 868.5120). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (1 Class I). FDA data exported November 2, 2026.
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- Product code
- OFU
- Device class
- 2
- Regulation
- 868.5120
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Canada | 1 |
| Mexico | 1 |
Makers of Spinal Anesthesia Kit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 0 | 0 | 1 | 1 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CHS USA Incorporated | Peachtree City, GA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Custom Interventional Pain Management | San Antonio, TX, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Canadian Hospital Specialties Ltd. | OAKVILLE Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| International Sterilization Laboratory, LLC | Groveland, FL, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.