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 monitoring capabilities; English language Surveyor Central Station with S4 Wifi telemetry monitoring capabilities; English language and CD manual; Configured CPU (custom SCNODE configuration must be determined) with 220V power and dual color LCD 24" monitors with high resolution; 0 hard wired patient monitoring slots and 16 telemetry channels (dual display recommended); Redundant server (RAID1+0) storage for up to 1,200 days, 110V HP LaserJet network printer; VERITAS analysis algorithm with 12-lead ECG interpretation, extended arrhythmi

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More Product Details

Catalog Number

SCSYS-HAB-GHFCA

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

DPS

Product Code Name

Electrocardiograph

Device Record Status

Public Device Record Key

369ccfd1-9476-4358-8d79-16ef54cf2155

Public Version Date

June 27, 2022

Public Version Number

2

DI Record Publish Date

September 29, 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