Data / Medical devices / United States / CSL Behring LLC
CSL Behring LLC: FDA-registered device maker in Bradley, IL, United States, 5 510(k) clearances
CSL Behring LLC is registered with the FDA (registration 1410248) in Bradley, IL, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 14, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1410248
- Address
- 1201 N Kinzie Ave, Bradley, IL, United States, 60915
- Owner or operator
- CSL Behring LLC (10042341)
- Roles
- Repackager or relabeler
- First device listed
- November 16, 2012
- Registered through
- 2026
- Brand names listed
- B. Braun Injekt piston syringe, Mix2Vial(TM), Nipro SafeTouch PSV Scalp Vein Set with Safety Device, Safety Glide Needle, Surflo Winged Infusion Set with Needle Protection (Surshield)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Repackager or relabeler | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Repackager or relabeler | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 14, 2014 | K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE | FOZ | Substantially Equivalent | Nipro Medical Corporation | accessdata.fda.gov |
| February 5, 2014 | K133867 | SURFLO WINGED INFUSION SET WITH NEEDLE PROTECTION (SURSHIELD) | FPA | Substantially Equivalent | Terumo Europe N.V. | accessdata.fda.gov |
| November 17, 2006 | K063280 | INJEKT SYRINGE | FMF | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| July 29, 2003 | K031861 | MIX2VIAL TRANSFER DEVICE | LHI | Substantially Equivalent | Medimop Medical Projects, Ltd. | accessdata.fda.gov |
| October 7, 1995 | K951254 | SAFETYGLIDE NEEDLE | FMI | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic | accessdata.fda.gov |
Compare with other makers
- All makers of Set, I.V. Fluid Transfer
- All makers of Syringe, Piston
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Set, Administration, Intravascular
Updated February 14, 2014. 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.