BIONIX DEVELOPMENT CORPORATION 1100

GUDID 00859911004351

Sample- Swaddler for PhotoTherapy, preemie

BIONIX DEVELOPMENT CORPORATION

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 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

• Primary Device ID: 00859911004351
• NIH Device Record Key: 74449716-5de4-4599-86d9-275e3e54283d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Version Model Number: SP-21100
• Catalog Number: 1100
• Company DUNS: 602736795
• Company Name: BIONIX DEVELOPMENT CORPORATION
• 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: 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	00859911004351 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-22

On-Brand Devices [BIONIX DEVELOPMENT CORPORATION]

• 00859911004405: DeClogger Starter Pack
• 00859911004399: Wound Irrigation System
• 00859911004382: Wound Irrigation- 25ct
• 00859911004375: Wound Irrigation- 50ct
• 00859911004368: Sample- Swaddler for PhotoTherapy, normal
• 00859911004351: Sample- Swaddler for PhotoTherapy, preemie
• 00859911004344: Sample- DeClogger 18-24 F/Orange
• 00859911004337: Sample-DeClogger 14-16 F/Brown
• 00859911004320: Sample- DeClogger 20-22 F/Green
• 00859911004313: Sample-DeClogger 16-18 F/Yellow
• 00859911004306: Sample-DeClogger 14-16 F/Blue
• 00859911004214: Box of 20 OtoClear Tips
• 00859911004207: Disposable Speculum-20 count
• 00859911004191: Disposable Speculum-48 count
• 00859911004184: Box of 3 Ear Basins
• 00859911004160: Box of 40 OtoClear Tips
• 00859911004153: SprayWash Kit
• 00859911004146: Ear Lavage System