AccessGUDID - DEVICE: UltraviewSL (10841522108778)

GUDID

Device Identifier (DI) Information

Brand Name: UltraviewSL
Version or Model: 91496
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: R-91496-M
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522108778
Issuing Agency: GS1
Commercial Distribution End Date: May 26, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: OPTION, MASIMO SPO2, REFURBISHED

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?
36553	Patient monitoring system module, multifunction	A small unit dedicated to the measurement and displays of several physiological parameters, e.g., electrical activity of the heart, respiratory rate, temperature, blood pressure, pulse, and oximetry. The signals are obtained through connected cables/leads/probes. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device which then operates as a mainframe computer displaying the various parameters/information measured and provided by this module.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
DQA	Oximeter
FLL	Thermometer, electronic, clinical
DSK	COMPUTER, BLOOD-PRESSURE
DSI	DETECTOR AND ALARM, ARRHYTHMIA
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103142	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: 81aa3fc7-b7eb-4ab0-801d-7188426060e7
Public Version Date: May 08, 2024
Public Version Number: 5
DI Record Publish Date: November 15, 2016