BIONIX DEVELOPMENT CORPORATION 9510

GUDID 00859911004917

GASTROFLUSH 10CT.

M&H Medical Holdings, Inc.

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• Primary Device ID: 00859911004917
• NIH Device Record Key: 1bf45f84-e1fc-4ad4-b032-53142ddbc5c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Version Model Number: GF-09510
• Catalog Number: 9510
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• 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
• 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	00859911004917 [Package]; Contains: 10859911004914; Package: BOX [10 Units]; In Commercial Distribution
GS1	10859911004914 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180605

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: 2
• Public Version Date: 2023-07-10
• Device Publish Date: 2019-03-02

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