BIONIX DEVELOPMENT CORPORATION 1105

GUDID 00859911004283

Swaddler for PhotoTherapy, normal

M&H Medical Holdings, Inc.

Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket Phototherapy infant blanket

• Primary Device ID: 00859911004283
• NIH Device Record Key: 16d02875-59a7-43b7-a1b7-332fb4ffe725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Version Model Number: NP-1105
• Catalog Number: 1105
• 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
• 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: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com
• Phone: +1(800)551-7096
• Email: Bionix@bionix.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859911004283 [Package]; Contains: 10859911004280; Package: box [10 Units]; In Commercial Distribution
GS1	10859911004280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123411

FDA Product Code

• PDH: blanket, neonatal phototherapy

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: 2017-02-01

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