AccessGUDID - DEVICE: DR -HOS (06970742221671)

GUDID

Device Identifier (DI) Information

Brand Name: DR -HOS
Version or Model: DHGEL
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Guangzhou Xinbo Electronic Co., Ltd.

Primary DI Number: 06970742221671
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 530683813 *Terms of Use

Device Description: Conductive Electrode Gel: a conductive medium for use on fabric or metal electrodes

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):	No
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?
32544	Mediastinal drainage catheter, non-antimicrobial	A tube designed to establish a channel for the removal of fluid or purulent material from the mediastinum (the central compartment of the thoracic cavity); it is not coated with an antimicrobial agent. It is typically used in conjunction with, or as a component of, a drainage system that uses a low negative pressure through the drain lumen. It is typically made of silicone, available in various designs, shapes, and sizes, and may include disposable devices dedicated to catheter introduction; it does not include any fluid collection bags/containers. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GYB	Media, Electroconductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200402	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: 66a5e812-8a24-4ae3-b859-249aefada989
Public Version Date: August 24, 2021
Public Version Number: 1
DI Record Publish Date: August 16, 2021