Ultraview

Basic Information

• Brand Name: Ultraview
• Primary DI: 10841522107764
• Version / Model: 91424
• Catalog Number: L-91424-A
• Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC
• Labeler DUNS: 145581588
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-10
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 54efb705-4d6c-4ed0-b981-10b158222e47
• Distribution End Date: 2017-03-10

Device Description

BASE UNIT, SV02/SCV02 MODULE, 91424, LOANER ONLY

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
DQA	Oximeter	Cardiovascular	870.2700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37172	Patient monitoring system module, intracardiac oximetry	A small unit designed to measure the ratio of oxyhaemoglobin (O2Hb) to reduced haemoglobin (RHb) and/or deoxyhaemoglobin (HHb) within the heart by comparing the absorption of red and infrared light in the blood [mixed venous oxygen saturation (SvO2)]. A fibreoptic probe is inserted into the pulmonary artery, often a Swan-Ganz catheter, to detect the SvO2 levels. It is designed to operate as part of a patient monitoring system enhancing the function of this parent device. The module automatically plugs into the parent device when placed into a standardized slot in the parent device which then operates as a mainframe computer displaying the SvO2 information measured by this module.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841522107764	GS1

Premarket Submissions

Submission Number	Supplement Number
K893867	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 95 Percent (%) Relative Humidity