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Commander Flex®

FDA UDI

Class II (US FDA UDI)

by Medtronic Care Management Services

Identity

Trade Name
Commander Flex® FDA UDI
Generic Name
Multiple physiological parameter spot-check system, home-use FDA UDI
Device Name
HUB CD310A CMDR FLEX CE W/ ENG. MEDIA FDA UDI
Model / Reference
100011-015 FDA UDI
Description
HUB CD310A CMDR FLEX CE W/ ENG. MEDIA FDA UDI

Identifiers

Primary DI / UDI-DI
00643169838390 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Multiple physiological parameter spot-check system, home-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Multiple physiological parameter spot-check system, home-use

Commander Flex® by Medtronic Care Management Services — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple physiological parameter spot-check system, home-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Care Management Services

Sources (1)

  • FDA UDI 4158591e-1b72-4dd6-a233-0c0930eb6e79 35 fields · synced May 30, 2026