Welch Allyn, Inc. - Surveyor Central Station with S4 Wifi telemetry - WELCH ALLYN, INC.

Duns Number:198227881

Device Description: Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitor Surveyor Central Station with S4 Wifi telemetry and S12/S19 multiparameter bedside monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 110V power and dual color LCD 24" monitors with high resolution; 24 hard wired patient monitoring slots and 0 telemetry channels (dual display required); Local storage for up to 600 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended

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More Product Details

Catalog Number

SCSYS-IAE-HFFAX

Brand Name

Welch Allyn, Inc.

Version/Model Number

901137

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

MHX

Product Code Name

MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

Device Record Status

Public Device Record Key

92e7a1f0-31a4-4d6f-9617-f128e19e897f

Public Version Date

June 27, 2022

Public Version Number

2

DI Record Publish Date

February 15, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WELCH ALLYN, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 374
2 A medical device with a moderate to high risk that requires special controls. 4080
3 A medical device with high risk that requires premarket approval 1