Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004594267

FEI Number

3004594267

Entity Name

Medtronic Care Management Services

City/State/Country

Lafayette, CO, US

Establishment Address

200 Medtronic Dr, Lafayette, CO 80026, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091821

PMA Number

N/A

All Registered Proprietary Names

Stand-on Patient Scale SC250 Stand-on Patient Scale SC100 ForaCare Blue Tooth Weight Scale Test n Go 550 IHEALTH Scale HS4 Generic cables to connect Commander hub devices to various scales Commander Flex CD320 Generic cables to connect Commander hub devices to the various glucose meters Pulse Oximeter PO100 Generic cables to connect Commander hub devices to peak flow meter Generic cables to connect Commander hub devices to Pulse Oximeter Blood Pressure Cuff - Large Cuff Regular Blood Pressure Cuff - Medium Cuff Regular Blood Pressure Cuff - Large Cuff Contour Blood Pressure Cuff - Medium Cuff Contour Generic cables to connect Commander hub devices to the various Spirometers Blood Pressure Cuff - Small Cuff Regular Generic cables to connect Commander hub devices to the various thermometers Generic cables to connect Commander hub devices to the various Peak Flow meters Generic cables to connect Commander hub devices to the various stethoscopes

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	2016-12-02
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2016-12-02
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2016-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K100940	Andon Health Co, Ltd.	FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965	2010-06-29
K251581	Shenzhen Hingmed Medical Instrument Co., Ltd.	Wearable Ambulatory Blood Pressure Monitor (WBP-02A)	2026-02-13
K200521	Health & Life Co., Ltd.	Full Automatic(NIBP) Blood Pressure Monitor	2020-06-12

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-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004594267. Last updated year: 2026. Please use registration number 3004594267 when referencing this establishment in official correspondence.