AccessGUDID - DEVICE: Bandage for NMT sensor (06944904090603)

GUDID

Device Identifier (DI) Information

Brand Name: Bandage for NMT sensor
Version or Model: 040-002258-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Primary DI Number: 06944904090603
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:	Yes
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?
59690	Neuromuscular transmission electrode/sensor lead	A non-sterile insulated metal wire(s) designed to conduct electrical signals between neuromuscular transmission (NMT) electrodes and sensors placed on a patient's body and a patient monitoring system module, intended for the monitoring of patient relaxation to determine the level of neuromuscular block and the localization of a nerve in an area of the body. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KOI	Stimulator, Nerve, Peripheral, Electric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182075	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: e5f792e2-e43d-4e7c-9dce-fddecdbbe2e7
Public Version Date: May 07, 2020
Public Version Number: 1
DI Record Publish Date: April 29, 2020