AccessGUDID - DEVICE: JB CERVELLO 32 (00850154007048)

GUDID

Device Identifier (DI) Information

Brand Name: JB CERVELLO 32
Version or Model: 7512
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7512
Company Name: BLACKROCK NEUROMED, LLC

Primary DI Number: 00850154007048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 069799474 *Terms of Use

Device Description: JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bipolar, to be used with CERVELLO 32 Series Headboxes

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
35626	Electroencephalography telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit electroencephalographic (EEG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GWL	Amplifier, Physiological Signal
GWQ	Full-Montage Standard Electroencephalograph
OLV	Standard Polysomnograph With Electroencephalograph
GWK	Conditioner, Signal, Physiological

FDA Premarket Submission

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

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: 18cb576d-738e-45a7-ac61-99685b3d8cec
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 06, 2016