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Welch Allyn, Inc.

FDA UDI

Class II (US FDA UDI)

by Welch Allyn, Inc.

Identity

Trade Name
Welch Allyn, Inc. FDA UDI
Generic Name
Cardiopulmonary stress exercise monitoring system computer FDA UDI
Device Name
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, ba FDA UDI
Model / Reference
901144 FDA UDI
Description
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output and RScribe with Interpretation; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer (includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, ba FDA UDI

Identifiers

Catalog Number
XSCRIBE-6EA-DDBAB FDA UDI
Primary DI / UDI-DI
00732094259346 FDA UDI
FDA Product Code
DPS FDA UDI
GMDN Term
Cardiopulmonary stress exercise monitoring system computer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2340 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Category: Cardiopulmonary stress exercise monitoring system computer

Welch Allyn, Inc. by Welch Allyn, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiopulmonary stress exercise monitoring system computer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Welch Allyn, Inc.

Sources (1)

  • FDA UDI 4b69b53d-2658-46f3-97f9-2df417162501 35 fields · synced May 29, 2026