AccessGUDID - DEVICE: 3-Lead,New Telemetry,AHA,Pinch,24″ (06944904054544)

GUDID

Device Identifier (DI) Information

Brand Name: 3-Lead,New Telemetry,AHA,Pinch,24″
Version or Model: EY6316A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 009-004771-00
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904054544
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 654671304 *Terms of Use

Device Description: No description.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Multi-patient physiologic monitoring system	An assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring of ambulatory patients. The system is used to evaluate and observe trends in compromised or unstable patients in intensive or general healthcare settings.

GMDN Preferred Term Name

GMDN Definition

Multi-patient physiologic monitoring system

An assembly of devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring of ambulatory patients. The system is used to evaluate and observe trends in compromised or unstable patients in intensive or general healthcare settings.

FDA Product Code

[?]

Product Code	Product Code Name
MSX	System,Network And Communication,Physiological Monitors

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K150632	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c3c77f3a-7b64-49ec-a432-7bf335b88595
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 23, 2015