AccessGUDID - DEVICE: 12-Lead Leadset,Limb,AHA,Snap (06944904004785)

GUDID

Device Identifier (DI) Information

Brand Name: 12-Lead Leadset,Limb,AHA,Snap
Version or Model: 0010-30-42906
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904004785
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":	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

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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
Electrocardiographic lead set, reusable	A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Electrocardiographic lead set, reusable

A collection of noninvasive devices intended to be used to conduct electrical signals from a patient's heart, via an electrode attached to the surface of the chest/limbs, to an electrocardiograph (ECG) machine or a patient monitoring system. It includes an insulated metal wire(s) with a detachable or permanently attached electrode, and may include a cable with connector; some types may be designed as a pre-configured array (e.g., EEG belt) to assist electrode placement. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143195	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: 2c3d567f-7b1b-4855-a759-605a472d94e3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016