Data / Medical devices / United States / Optum Distribution Center, LLC

Optum Distribution Center, LLC: FDA-registered device maker in Marietta, GA, United States, 5 510(k) clearances

Name: Optum Distribution Center, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Optum Distribution Center, LLC is registered with the FDA (registration 3009456923) in Marietta, GA, United States. It lists 7 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 10, 2023. 1 recall event names it as the recalling firm (1 Class I). Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3009456923
Address: 877 Franklin Rd # 205, Marietta, GA, United States, 30067
Owner or operator: UnitedHealth Group (10045256)
Roles: Manufacturer, Repackager or relabeler
First device listed: November 4, 2020
Registered through: 2027

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Pump, Infusion	MRZ	2	Repackager or relabeler	accessdata.fda.gov
Intravenous Extension Tubing Set	OJA	2	Manufacturer	accessdata.fda.gov
Pump, Infusion	FRN	2	Repackager or relabeler	accessdata.fda.gov
Pump, Infusion, Pca	MEA	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Manufacturer	accessdata.fda.gov
System, Test, Blood Glucose, Over The Counter	NBW	2	Manufacturer	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
March 10, 2023	K213744	Avoset Infusion Pump System	FRN	Substantially Equivalent	Eitan Medical , Ltd.	accessdata.fda.gov
December 23, 2021	K193407	Contour® next GEN Blood Glucose Monitoring System	NBW	Substantially Equivalent	Ascensia Diabetes Care	accessdata.fda.gov
December 13, 2018	K181131	Accu-Chek Guide Me Blood Glucose Monitoring System	NBW	Substantially Equivalent	Roche Diabetes Care	accessdata.fda.gov
August 30, 2016	K153193	Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System, EVAA Ambulatory Infusion System)	FRN	Substantially Equivalent	Zyno Medical, LLC	accessdata.fda.gov
October 7, 2014	K141160	A&D MEDICAL UA-651 DIGITAL BLOOD PRESSURE MONITOR	DXN	Substantially Equivalent	A & D Co., Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 18, 2024	94491	Class I	Ongoing	Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump	Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstream occlusion, system errors, drug product leakage, high or low flow rate, or damaged pump housing.	accessdata.fda.gov

Compare with other makers

Updated May 21, 2024. 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.