Ultraview SL

Basic Information

• Brand Name: Ultraview SL
• Primary DI: 10841522106439
• Version / Model: Ultraview SL®
• Catalog Number: 91496-U
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-07
• Public Version: 8
• Public Version Date: 2023-10-26
• Public Version Status: Update
• Public Device Record Key: 0149bb22-cba4-4c69-a532-e0f3f1fbba44

Device Description

OPTION,SPACELABS SPO2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DSK	COMPUTER, BLOOD-PRESSURE	Cardiovascular	870.1110	2
DXG	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION	Cardiovascular	870.1435	2
DXN	SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE	Cardiovascular	870.1130	2
FLL	Thermometer, electronic, clinical	General Hospital	880.2910	2
DQA	Oximeter	Cardiovascular	870.2700	2
DSI	DETECTOR AND ALARM, ARRHYTHMIA	Cardiovascular	870.1025	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841522106439	GS1

Premarket Submissions

Submission Number	Supplement Number
K103142	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 75 Degrees Celsius