AccessGUDID - DEVICE: 740 SELECT (00851920007422)

GUDID

Device Identifier (DI) Information

Brand Name: 740 SELECT
Version or Model: 740 SELECT-XN0EW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01-02-1049
Company Name: ZOE MEDICAL INCORPORATED

Primary DI Number: 00851920007422
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 848429929 *Terms of Use

Device Description: The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.

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":	Yes
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
MWI	Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150620	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
Handling Environment Temperature: between 0 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: bef287ea-3df8-4687-8433-a865753b0385
Public Version Date: November 10, 2021
Public Version Number: 3
DI Record Publish Date: August 12, 2020