AccessGUDID - DEVICE: Ultraview SL® (10841522106293)

GUDID

Device Identifier (DI) Information

Brand Name: Ultraview SL®
Version or Model: Ultraview SL®
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 91424-A
Company Name: SPACELABS HEALTHCARE (WASHINGTON), INC

Primary DI Number: 10841522106293
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145581588 *Terms of Use

Device Description: BASE UNIT, SVO2/SCVO2 MODULE,91424

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DQA	Oximeter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K893867	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 70 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: f455ca58-c9ac-433b-afd3-0d8d5fc734d7
Public Version Date: October 26, 2023
Public Version Number: 6
DI Record Publish Date: September 28, 2016