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Life Science Logistics, LLC: FDA-registered device maker in Brownsburg, IN, United States, 3 510(k) clearances

Name: Life Science Logistics, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Life Science Logistics, LLC is registered with the FDA (registration 3009057691) in Brownsburg, IN, United States. It lists 8 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 1, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009057691
Address: 1105 East Northfield Drive, Brownsburg, IN, United States, 46112
Owner or operator: LifeScience Logistics, LLC (10051139)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler
First device listed: July 16, 2021
Registered through: 2026
Brand names listed: Vibrating Mesh Nebulizer

Devices it lists

Device	Product code	Class	Role	Source
Confocal Optical Imaging	OWN	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscope, Accessories, Narrow Band Spectrum	NWB	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Laparoscope, Gynecologic (And Accessories)	HET	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Microscope, Surgical	EPT	1	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Complaint file establishment	accessdata.fda.gov
System, X-Ray, Angiographic	IZI	2	Manufacturer, 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
July 1, 2021	K202171	Pulmogine Vibrating Mesh Nebulizer	CAF	Substantially Equivalent	Hcmed Innovations Co., Ltd.	accessdata.fda.gov
July 17, 2020	K200542	Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head	OWN	Substantially Equivalent	Olympus Medical Systems Corp.	accessdata.fda.gov
October 10, 2019	K190772	SURGICAL MICROSCOPE SYSTEM ORBEYE with IR	IZI	Substantially Equivalent	Olympus Medical Systems Corp.	accessdata.fda.gov

Compare with other makers

Updated July 1, 2021. 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.