Data / Medical devices / United States / Health Care Logistics, Inc.
Health Care Logistics, Inc.: FDA-registered device maker in Urbancrest, OH, United States, 8 510(k) clearances
Health Care Logistics, Inc. is registered with the FDA (registration 1530671) in Urbancrest, OH, United States. It lists 19 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 6, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1530671
- FEI number
- 3001639729
- Address
- 3605 Urbancrest Industrial DR., Urbancrest, OH, United States, 43123
- Owner or operator
- Health Care Logistics, Inc. (9032160)
- Roles
- Repackager or relabeler
- First device listed
- May 13, 2002
- Registered through
- 2026
- Brand names listed
- BetterShield Disposable Face Shield, Biohazard Transport Bags, BlueMed Shoe Cover, Bouffant Cap, Chemo Vent, Chemotherapy Disposal Slider Bag, Chemotherapy Waste Bag, Disposable Full Face Shield and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| August 6, 2019 | K190502 | ENFit Oral / Enteral Syringe | PNR | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| January 11, 2019 | K182545 | Tamper Evident Cap with Male Luer Lock | FPA | Substantially Equivalent | International Medical Industries, Inc. | accessdata.fda.gov |
| March 22, 1995 | K943660 | PHLEBOTOMY SHARPS DISPOSAL CONTAINERS | MMK | Substantially Equivalent | Sage Products, Inc. | accessdata.fda.gov |
| October 23, 1992 | K922716 | SPLASH SHIELD # 4505, 4507, PARASHIELD # 4509 | FXX | Substantially Equivalent | Splash Shield, Inc. | accessdata.fda.gov |
| October 9, 1987 | K872743 | BAXA TUBING SETS (FOR PHARMACY PUMP) | FMF | Substantially Equivalent | Baxa Corp., Sub. of Cook Group, Inc. | accessdata.fda.gov |
| February 12, 1986 | K860434 | CHEMO-VENT | LHI | Substantially Equivalent | Intl. Medical Industries | accessdata.fda.gov |
| September 19, 1985 | K853212 | FLOW EASE(PLASTIC VENTED NEEDLE) | LHI | Substantially Equivalent | Acacia, Inc. | accessdata.fda.gov |
| January 21, 1981 | K802765 | ACRODISC FILTER ASSEMBLY | FPB | Substantially Equivalent | Gelman Sciences, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Nasal Spray, Ent Delivery
- All makers of Cover, Shoe, Operating-Room
- All makers of Filter, Infusion Line
- All makers of Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- All makers of Container, Specimen Mailer And Storage, Non-Sterile
- All makers of Cap, Surgical
Updated August 6, 2019. 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.