Swaddler for Phototherapy

Basic Information

• Brand Name: Swaddler for Phototherapy
• Primary DI: 00859911004283
• Version / Model: 1105
• Catalog Number: 1105
• Company Name: Bionix, LLC
• Labeler DUNS: 117844489
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-02-01
• Public Version: 6
• Public Version Date: 2023-11-30
• Public Version Status: Update
• Public Device Record Key: 16d02875-59a7-43b7-a1b7-332fb4ffe725

Device Description

Swaddler for PhotoTherapy: Newborn, regular

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
64254	Phototherapy infant blanket	A piece of fabric, made of an ultraviolet (UV) light-transmittable material, intended to be used to wrap a newborn/infant during UV phototherapy for the treatment of neonatal jaundice (neonatal hyperbilirubinemia) to enable therapeutic light to pass through to the patient while simultaneously providing comfort. It does not include a light source. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859911004283	GS1
Unit of Use	10859911004280	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123411	000