AccessGUDID - DEVICE: Ultraview (10841522105333)

GUDID

Device Identifier (DI) Information

Brand Name: Ultraview
Version or Model: 90478
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522105333
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: MDTM REC,DL,EN,UHF U

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?
36365	Electrocardiography monitoring system receiver	An electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor).	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 [?]
K983996	000

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 Temperature: between -40 and 75 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 91c8696a-8c9e-4bef-8deb-9fc29834e22c
Public Version Date: November 28, 2022
Public Version Number: 2
DI Record Publish Date: January 23, 2019