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EC-View

FDA UDI

Class II (US FDA UDI)

by Cardio Command

Identity

Trade Name
EC-View FDA UDI
Generic Name
Electrocardiographic lead/catheter adaptor FDA UDI
Device Name
An ECG adapter for the Tapscope, which provides an esophageal ECG. FDA UDI
Model / Reference
ECG adapter FDA UDI
Description
An ECG adapter for the Tapscope, which provides an esophageal ECG. FDA UDI

Identifiers

Catalog Number
8028 FDA UDI
Primary DI / UDI-DI
00856233005141 FDA UDI
PMA Number
P860008 FDA UDI
FDA Product Code
BZT FDA UDI
GMDN Term
Electrocardiographic lead/catheter adaptor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.1920 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

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

Yes

FDA UDI

Category: Electrocardiographic lead/catheter adaptor

EC-View by Cardio Command — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrocardiographic lead/catheter adaptor.

Cleared under the same submission

P860008 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardio Command

Sources (1)

  • FDA UDI 3fedbb07-17e3-4c72-bf37-0300178166b7 36 fields · synced May 30, 2026