AccessGUDID - DEVICE: BRAEBON Leadwire Kit for MediByte (B14086201)

GUDID

Device Identifier (DI) Information

Brand Name: BRAEBON Leadwire Kit for MediByte
Version or Model: 8620
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8620
Company Name: Braebon Medical Corporation

Primary DI Number: B14086201
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 7
Labeler D-U-N-S® Number*: 251731105 *Terms of Use

Device Description: Leads for connecting electrodes to a MediByte.

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?
35562	Electrocardiographic lead set, reusable	A collection of noninvasive devices intended 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 is designed as an insulated wire(s), which may additionally include a detachable or permanently attached electrode and/or 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNR	Ventilatory Effort Recorder

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061764	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
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 24 Inch
Length: 60 Inch

Device Record Status

Public Device Record Key: ed40f5af-8431-4094-9967-00ab87fe0a86
Public Version Date: June 06, 2024
Public Version Number: 4
DI Record Publish Date: September 22, 2016