AccessGUDID - DEVICE: Welch Allyn, Inc. (00732094318234)

GUDID

Device Identifier (DI) Information

Brand Name: Welch Allyn, Inc.
Version or Model: 901137
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SCSYS-IAA-DBFXX
Company Name: WELCH ALLYN, INC.

Primary DI Number: 00732094318234
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 198227881 *Terms of Use

Device Description: SC Station S4 Wifi telemetry and S12/S19 multiparameter bedside monitor capabilities EN CD man Config CPU custom SCNODE config must be determined w/ 110V pwr and dual color LCD 24" high res monitor 16 hard wired pat. monitor slots and 0 telemetry ch dual display recommend Local storage 600 days no network printer VERITAS analysis algorithm 12-lead ECG interp ext. arrhythmia 12-lead ST segment monitor and hemodynamic calc required for options with hard wired pat. monitor slots No full disclosure

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7a500871-76c3-4a41-a9b5-ba23e1062b25
Public Version Date: May 03, 2023
Public Version Number: 1
DI Record Publish Date: April 25, 2023