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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
Patient monitoring system module, electrocardiographic FDA UDI
Device Name
S2 telemetry transmitter supporting a 4 and 5 wire patient cable for diagnostic quality ECG acquisition and transmission via standard IEEE 802.11a b g n WLAN at 2.4 and 5 GHz , capacitive touch control and menu navigation with 2.8 inch antiglare color display , heart rate display when actively communicating with monitoring node , water resistant protection with IPX4 rating , includes rechargeable Lithium ion battery pack with 32 hour typical runtime, single use clip on pouch and user instructions. FDA UDI
Model / Reference
901139 FDA UDI
Description
S2 telemetry transmitter supporting a 4 and 5 wire patient cable for diagnostic quality ECG acquisition and transmission via standard IEEE 802.11a b g n WLAN at 2.4 and 5 GHz , capacitive touch control and menu navigation with 2.8 inch antiglare color display , heart rate display when actively communicating with monitoring node , water resistant protection with IPX4 rating , includes rechargeable Lithium ion battery pack with 32 hour typical runtime, single use clip on pouch and user instructions. FDA UDI

Identifiers

Catalog Number
S2-P-AXX-XXX FDA UDI
Primary DI / UDI-DI
00732094323931 FDA UDI
FDA Product Code
DRG FDA UDI
GMDN Term
Patient monitoring system module, electrocardiographic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2910 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

Yes

FDA UDI

Category: Patient monitoring system module, electrocardiographic

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

Similar devices

Also classified as Patient monitoring system module, electrocardiographic.

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 8b503769-a283-4e0f-a03d-a94e3300f92d 35 fields · synced May 29, 2026