WELCH ALLYN, INC.

Address:7865 NORTH 86TH ST.,MILWAUKEE,WI,53224,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Oximeter (DQA) (9) SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE (DXN) (1)

Premarket Exempt

No Yes

Clear

Welch Allyn, Inc. - 00732094003192 Catalog Number : 45NE0-E1G

Device Description : Welch Allyn Spot LXi Vital Signs Device with Nellcor SpO2, Braun ThermoScan PRO

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003208 Catalog Number : 45NE0-E1

Device Description : Welch Allyn Spot LXi Vital Signs Device with Nellcor SpO2, Braun ThermoScan PRO

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003314 Catalog Number : 45MT0-E4

Device Description : Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, SureTemp Plus Thermome

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003321 Catalog Number : 45MT0-E2

Device Description : Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, SureTemp Plus Thermome

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003352 Catalog Number : 45MT0-E1G

Device Description : Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, SureTemp Plus Thermome

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003369 Catalog Number : 45MT0-E1

Device Description : Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, SureTemp Plus Thermome

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003512 Catalog Number : 45ME0-E1R

Device Description : Spot Vital Signs LXi with SureBP, Masimo SpO2, Braun Thermoscan PRO 4000 (FACTOR

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DXN

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003529 Catalog Number : 45ME0-E1G

Device Description : Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, Braun ThermoScan PRO 4

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003536 Catalog Number : 45ME0-E1

Device Description : Welch Allyn Spot LXi Vital Signs Device with Masimo SpO2, Braun ThermoScan PRO 4

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Welch Allyn, Inc. - 00732094003666 Catalog Number : 450T0-E1G

Device Description : Welch Allyn Spot LXi Vital Signs Device with SureTemp Plus Thermometry, SureBP N

Device Class : 2

Duns Number: 198227881

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

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