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CardioSTAT

FDA UDI

Class II (US FDA UDI)

by Icentia Llc

Identity

Trade Name
CardioSTAT FDA UDI
Generic Name
Electrocardiographic ambulatory recorder FDA UDI
Device Name
CardioSTAT Installation Kit - ECG Recorder 14D Test FDA UDI
Model / Reference
10-006 FDA UDI
Description
CardioSTAT Installation Kit - ECG Recorder 14D Test FDA UDI

Identifiers

Primary DI / UDI-DI
27540279250142 FDA UDI
510(k) Number
K223049 FDA UDI
FDA Product Code
DSH FDA UDI
DQK FDA UDI
GMDN Term
Electrocardiographic ambulatory recorder FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2800 FDA UDI
870.1425 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Electrocardiographic ambulatory recorder

CardioSTAT by Icentia Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic ambulatory recorder.

Cleared under the same submission

K223049 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Icentia Llc

Sources (1)

  • FDA UDI 976ab761-59a1-4b4e-9b7c-5643cc8a6969 34 fields · synced May 29, 2026