Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009456923

FEI Number

3009456923

Entity Name

Optum Distribution Center, LLC

City/State/Country

Marietta, GA, US

Establishment Address

877 Franklin Rd, # 205, Marietta, GA 30067, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

UnitedHealth Group (Owner Number: 10045256)

Owner / Operator Contact Address

1 Health Drive, MN103-0400, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K181131

PMA Number

N/A

All Registered Proprietary Names

Bluetooth Dual Mode Body Scale

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRI	Scale, Stand-On, Patient	General Hospital	Class 1	880.2700	2015-05-15
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-08-30
OJA	Intravenous Extension Tubing Set	General Hospital	Class 2	880.5440	2026-03-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-11-04
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2023-08-30
LFR	Glucose Dehydrogenase, Glucose	Clinical Chemistry	Class 2	862.1345	2023-08-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2020-11-04
MEA	Pump, Infusion, Pca	General Hospital	Class 2	880.5725	2020-11-04
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2020-11-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-04-10
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2024-04-10
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-04-10
NBW	System, Test, Blood Glucose, Over The Counter	Clinical Chemistry	Class 2	862.1345	2026-06-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

UnitedHealth Group

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18
K830039	Science Development Corp.	SDC RECTAL TEMP. PROBE PRODUCT #1020	1983-02-23
K842199	Sharp Electronics Corp.	ELEC. DIGITAL THERMOMETER MT-20 & 30	1984-07-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025	MEDLINE INDUSTRIES, LP Northfield	2	MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0004-2009	Lifescan Inc	2	One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count. Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. Intended for use on the finger, arm, or palm.
Z-0042-06	Abbott Laboratories Medisense Products	2	FreeStyle FLASH Blood Glucose Monitoring System; Recalling Firm/Manufacturer: Abbott Diabetes Care, Inc., 1360 South Loop Road, Alameda, CA 94502

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3007047906	Nanjing Easthigh Measurement Co Ltd	Nanjing Jiangsu, CN
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3007695022	Guangdong Winburg Technology Co.,Ltd	ZHONGSHAN Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009456923. Last updated year: 2026. Please use registration number 3009456923 when referencing this establishment in official correspondence.