FDA.reportPublic FDA data

Commander Flex®

Primary DI
00643169838437
Brand
Commander Flex®
Company
Medtronic Care Management Services, LLC
Model
100011-026
Device description
HUB CD315 CMDR FLEX COMM. W/ ENG. MEDIA
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169838437PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169838437006431698384376431698384370643169838437

GMDN Terms#

Term, Definition table
TermDefinition
Multiple physiological parameter spot-check analysis system, home-useA mains electricity (AC-powered) device assembly, sometimes with a rechargeable battery, designed to electronically measure and display multiple patient physiological parameters [e.g., blood pressure, blood glucose, pulse rate, temperature, haemoglobin oxygen saturation (SpO2), and possibly calculate mean arterial pressure (MAP)] for intermittent spot-check measuring in the home. It typically includes a main analysis unit with a visual display, and ports for input of the system's measuring components (e.g., thermometer, blood pressure cuff, blood glucose meter) or external devices (e.g., USB cable). It may be used in a healthcare facility or in the home.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
061079989
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763000286972Commander Flex™101001-0012019-07-08
00763000286989Commander Flex™101001-0022019-07-08
00763000286996Commander Flex™101001-0032019-07-08
00763000001957Commander Flex™100011-0312017-06-23
00763000001964Linkview100011-0322017-06-23
00643169838338Commander100016-001A2016-09-10
00643169838345Commander100016-0032016-09-05
00643169838352Commander100016-005A2016-09-09
00643169838369Commander100011-001A2016-09-05
00643169838376Commander100011-002A2016-09-05
00643169838383Commander Flex®100011-0132016-09-08
00643169838390Commander Flex®100011-0152016-09-08
00643169838406Commander Flex®100011-0172016-09-08
00643169838413Commander Flex®100011-0162016-09-08
00643169838420Commander Flex®100011-0202016-09-08
00643169838444Commander Flex®100011-0302016-09-08
00643169838451Linkview®100011-0222016-09-08
00643169838468NA100027-001A2016-09-05
00643169838482NA450001-0142016-09-08
00643169838499NA450001-0202016-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06920485308580P PANACAREShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-26
06944413835153Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DXN2026-08-26
00634782102265Advantage™AMERICAN DIAGNOSTIC CORPDXN2026-08-25
00810226442306ViveVIVE HEALTH LLCDXN2026-08-25
00856324008778PARAMEDSILEX GLOBAL LLCDXN2026-08-22
06971522821753LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06971522821760LineshareShenzhen Finicare Co., LtdDXN2026-08-22
06953825911805FOCUSED ADULT ADHD CLINICShenzhen Urion Technology Co., LtdDXN2026-08-19
09120073932778CNAP® ArmslingCNSystems Medizintechnik GmbHDXN2026-08-18
09120073932785CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932792CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932808CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932815CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932822CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932839CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932846CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932853CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932860CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932877CNAP® double finger cuff "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932884CNAP® double finger cuff "medium"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073932891CNAP® double finger cuff "large"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933034CNAP® Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
09120073933041TFC Armsling "small"CNSystems Medizintechnik GmbHDXN2026-08-18
06953825911799SAKERShenzhen Urion Technology Co., LtdDXN2026-08-17
06920485308542BSXShenzhen BSX Technology Electronics Co., Ltd.DXN2026-08-14
00057475244125BIOS DiagnosticsThermor LtdDXN2026-08-07
06953825911690PianieyShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911706SAKERShenzhen Urion Technology Co., LtdDXN2026-08-01
06953825911720N/AShenzhen Urion Technology Co., LtdDXN2026-08-01