← Back to catalogue

ECG Plug-In

FDA UDI

Class II (US FDA UDI)

by Preventice Technologies, Inc.

Identity

Trade Name
ECG Plug-In FDA UDI
Generic Name
Cardiopulmonary physiological parameter analysis software FDA UDI
Device Name
Monitor communication software application FDA UDI
Model / Reference
SW1003 FDA UDI
Description
Monitor communication software application FDA UDI

Identifiers

Primary DI / UDI-DI
00852132007309 FDA UDI
FDA Product Code
DSI FDA UDI
GMDN Term
Cardiopulmonary physiological parameter analysis software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1025 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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Cardiopulmonary physiological parameter analysis software

ECG Plug-In by Preventice Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary physiological parameter analysis software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Preventice Technologies, Inc.

Sources (1)

  • FDA UDI e783a7a4-8b77-4d6b-94dc-b3f70704015d 33 fields · synced May 30, 2026