AccessGUDID - DEVICE: BIONIX DEVELOPMENT CORPORATION (08599110040072)

GUDID

Device Identifier (DI) Information

Brand Name: BIONIX DEVELOPMENT CORPORATION
Version or Model: DG-912
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 912
Company Name: M&H Medical Holdings, Inc.

Primary DI Number: 08599110040072
Issuing Agency: GS1
Commercial Distribution End Date: February 01, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 602736795 *Terms of Use

Device Description: DeClogger 16-18 F/Yellow

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":	Yes
For Single-Use:	Yes
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?
59068	Ultrasonic cough stimulation system	An assembly of devices designed to stimulate a reflex cough using ultrasound in a patient who cannot cough on command, typically respiratory patients with cortical insufficiency (e.g., unconscious, comatose, anaesthetized, obtunded) or the very young/elderly, to help clear the lungs of secretions and aspirated materials (e.g., inhaled fluids or vomitus). It typically consists of: 1) a mains electricity (AC-powered) generator that produces amplified pulsed electrical signals; 2) a handpiece with ultrasonic transducers that convert the electrical signals to ultrasound for external application to the patient?s pharynx via disposable gel pads, to elicit cough reflex; and 3) a connecting cable.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K905164	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: a4937422-d40e-4a24-8f6c-9d9d3cfca82b
Public Version Date: July 10, 2023
Public Version Number: 4
DI Record Publish Date: October 26, 2016