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Change Healthcare Cardiology

FDA UDI

Class II (US FDA UDI)

by Change Healthcare Canada Company

Identity

Trade Name
Change Healthcare Cardiology FDA UDI
Generic Name
Cardiology information system FDA UDI
Model / Reference
14.3.2 FDA UDI

Identifiers

Primary DI / UDI-DI
17540262090055 FDA UDI
510(k) Number
K181080 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Cardiology information system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiology information system

Change Healthcare Cardiology by Change Healthcare Canada Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiology information system.

Cleared under the same submission

K181080 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Change Healthcare Canada Company

Sources (1)

  • FDA UDI 0012fb48-0f3c-436c-9ec5-36eb6e4c3901 33 fields · synced May 30, 2026