BIONIX DEVELOPMENT CORPORATION 1105

GUDID 00859911004368

Sample- Swaddler for PhotoTherapy, normal

BIONIX DEVELOPMENT CORPORATION

Blanket/pad infant phototherapy unit

• Primary Device ID: 00859911004368
• NIH Device Record Key: 63136f05-c0f4-46d4-a927-7f788b3716d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Version Model Number: SP-21105
• Catalog Number: 1105
• 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	00859911004368 [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