BIONIX DEVELOPMENT CORPORATION 912

GUDID 08599110040027

DeClogger 16-18 F/Yellow

M&H Medical Holdings, Inc.

Ultrasonic cough stimulation system

• Primary Device ID: 08599110040027
• NIH Device Record Key: a4937422-d40e-4a24-8f6c-9d9d3cfca82b
• Commercial Distribution Discontinuation: 2017-02-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Version Model Number: DG-912
• Catalog Number: 912
• Company DUNS: 602736795
• Company Name: M&H Medical Holdings, Inc.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx
• Phone: +1(800)551-7096
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	08599110040027 [Package]; Contains: 08599110040072; Package: box [10 Units]; Discontinued: 2017-02-01; Not in Commercial Distribution
GS1	08599110040072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905164

FDA Product Code

• KNT: TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2023-07-10
• Device Publish Date: 2016-10-26

On-Brand Devices [BIONIX DEVELOPMENT CORPORATION]

• 00859911004917: GASTROFLUSH 10CT.
• 00859911004283: Swaddler for PhotoTherapy, normal
• 00859911004276: Swaddler for PhotoTherapy, preemie
• 00859911004269: DeClogger 18-24 F/Orange
• 00859911004252: DeClogger 14-16 F/Brown
• 00859911004245: DeClogger 20-22 F/Green
• 00859911004238: DeClogger 16-18 F/Yellow
• 00859911004221: DeClogger 14-16 F/Blue
• 08599110040126: Swaddler for PhotoTherapy, normal
• 08599110040119: Swaddler for PhotoTherapy, preemie
• 08599110040058: DeClogger 18-24 F/Orange
• 08599110040041: DeClogger 14-16 F/Brown
• 08599110040034: DeClogger 20-22 F/Green
• 08599110040027: DeClogger 16-18 F/Yellow
• 08599110040010: DeClogger 14-16 F/Blue