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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 CD320 CMDR FLEX - GA FDA UDI
Model / Reference
101001-001 FDA UDI
Description
HUB CD320 CMDR FLEX - GA FDA UDI

Identifiers

Primary DI / UDI-DI
00763000286972 FDA UDI
510(k) Number
K091821 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.

Cleared under the same submission

K091821 also covers:

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 4682be36-8951-47ca-8d05-b2e7ab2f0a77 36 fields · synced May 30, 2026