AccessGUDID - DEVICE: Starling Monitor with SpO2 Module (72900130302906)

GUDID

Device Identifier (DI) Information

Brand Name: Starling Monitor with SpO2 Module
Version or Model: CMMST5S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CMMST5S
Company Name: CHEETAH MEDICAL (ISRAEL) LTD

Primary DI Number: 72900130302906
Issuing Agency: GS1
Commercial Distribution End Date: August 12, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 533390019 *Terms of Use

Device Description: A portable, non-invasive cardiac output (CO) monitoring device with SpO2 module.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
36872	Multiple vital physiological parameter monitoring system, clinical	An assembly of electrically-powered devices designed to be used by a healthcare professional in a clinical setting for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DSB	Plethysmograph, Impedance
DQA	Oximeter
DXN	System, Measurement, Blood-Pressure, Non-Invasive

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 Temperature: between 5 and 50 Degrees Celsius
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3493517e-eb66-439c-997e-c5a856510916
Public Version Date: August 01, 2023
Public Version Number: 8
DI Record Publish Date: April 07, 2021