AccessGUDID - DEVICE: EEG Cables and Lead Sets (00884838037922)

GUDID

Device Identifier (DI) Information

Brand Name: EEG Cables and Lead Sets
Version or Model: EEG CBL 4CH Trunk Cable, 2.7m
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 989803180541
Company Name: Philips Medizin Systeme Böblingen GmbH

Primary DI Number: 00884838037922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101143 *Terms of Use

Device Description: EEG Trunk Cable, 4 channel, reusable, 2, 7 meter (8.8 ft) long, shielded for 9 lead EEG monitoring. Use with 98980310561, 989803180521 or 989803180531 lead sets. The 4 channel trunk cable can also be used for 2 channels. In this case lead sets M1931A, M1932A, M1934A are recommended.

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47487	Electrical-only medical device connection cable, reusable	A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IKD	CABLE, ELECTRODE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Temperature: between -40 and 158 Degrees Fahrenheit
Storage Environment Atmospheric Pressure: between 10 and 107.5 KiloPascal
Storage Environment Humidity: between 0 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad8c601c-7f9f-42ca-b586-ee3fd9549708
Public Version Date: May 05, 2023
Public Version Number: 6
DI Record Publish Date: December 27, 2016