AccessGUDID - DEVICE: Surveyor Central (00812345028140)

GUDID

Device Identifier (DI) Information

Brand Name: Surveyor Central
Version or Model: SCREV-AAA-BXXXX
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MORTARA INSTRUMENT, INC.

Primary DI Number: 00812345028140
Issuing Agency: GS1
Commercial Distribution End Date: March 08, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 062046149 *Terms of Use

Device Description: Patient Monitoring Central Station

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):	Yes
Over the Counter (OTC):	No
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?
18119	Cardiology information system	A dedicated assembly of devices designed to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with the provision and utilization of cardiology services and facilities. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded).	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
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: less than 149 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c766600d-d628-4cb7-aa2f-8206be6f19b7
Public Version Date: March 09, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016