AccessGUDID - DEVICE: Ultraview (10841522102790)

GUDID

Device Identifier (DI) Information

Brand Name: Ultraview
Version or Model: 90478
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3.05.07EN
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522102790
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: KIT,TM MOD,MV0 ST TO MV2 ST

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:	Yes
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
No Product Codes

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: exactly 0 Percent (%) Relative Humidity
Storage Environment Temperature: exactly 0 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83ecd918-ed51-4f4d-81af-62d518ae8e4a
Public Version Date: November 28, 2022
Public Version Number: 3
DI Record Publish Date: March 12, 2018