BIONIX DEVELOPMENT CORPORATION

Basic Information

• Brand Name: BIONIX DEVELOPMENT CORPORATION
• Primary DI: 08599110040133
• Version / Model: NP-1100
• Catalog Number: 1100
• Company Name: M&H Medical Holdings, Inc.
• Labeler DUNS: 602736795
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-25
• Public Version: 5
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 964e1bd6-68fb-4ce2-b814-78c16ce344b6
• Distribution End Date: 2017-02-01

Device Description

Swaddler for PhotoTherapy, preemie

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PDH	blanket, neonatal phototherapy	General Hospital	880.5700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33791	Blanket/pad infant phototherapy unit	A device designed to emit a blue light in the visible wavelength of around 425-475 nm to treat neonatal jaundice (or hyperbilirubinemia). It consists of a light source that connects to a blanket-like wrap or pad which emits the light and covers or encloses the neonate's body. Exposure to this device will alter the bilirubin through photo oxidation and configurational and structural isomerization allowing the body function to dispose of it naturally. It is intended for use in the home and a clinical setting.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	08599110040119	GS1	box	10	Not in Commercial Distribution	2017-02-01
Primary	08599110040133	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123411	000