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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
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI
Device Name
Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device with SureBP Non-invasive Blood Pressure, Pulse Rate, MAP; Bluetooth Wireless Technology, Handheld; Lithium-ion (#BATT11) Battery; IEC Plug Type-A FDA UDI
Model / Reference
901055 FDA UDI
Description
Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device with SureBP Non-invasive Blood Pressure, Pulse Rate, MAP; Bluetooth Wireless Technology, Handheld; Lithium-ion (#BATT11) Battery; IEC Plug Type-A FDA UDI

Identifiers

Catalog Number
34BFHT-B FDA UDI
Primary DI / UDI-DI
00732094009408 FDA UDI
510(k) Number
K101680 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K101680 also covers:

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 10d6400f-936a-42ce-b0e4-3bd188b9c897 37 fields · synced May 31, 2026