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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
Multiple physiological parameter spot-check system, clinical FDA UDI
Device Name
Welch Allyn Spot LXi Vital Signs Device with SureTemp Plus Thermometry, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BMI Calculation, 50-Reading Memory, Connectivity Ready; 100-240 V, 50-60 Hz AC, Lithium Ion (#105632) Battery; IEC Plug Type-B FDA UDI
Model / Reference
901056 FDA UDI
Description
Welch Allyn Spot LXi Vital Signs Device with SureTemp Plus Thermometry, SureBP Non-invasive Blood Pressure, Pulse Rate, MAP, BMI Calculation, 50-Reading Memory, Connectivity Ready; 100-240 V, 50-60 Hz AC, Lithium Ion (#105632) Battery; IEC Plug Type-B FDA UDI

Identifiers

Catalog Number
450T0-E1 FDA UDI
Primary DI / UDI-DI
00732094003673 FDA UDI
FDA Product Code
DQA FDA UDI
GMDN Term
Multiple physiological parameter spot-check system, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.2700 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

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 6053604d-51f9-4cfd-9a2d-05e9b525eb78 36 fields · synced May 31, 2026