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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37595	Multiple-patient intensive/general healthcare physiologic monitoring system	An assembly of electrically-powered 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 in intensive or general healthcare settings. 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 programmable alarms, portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation.	Obsolete	false

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: February 06, 2020
Public Version Number: 4
DI Record Publish Date: October 23, 2015