Biotronix Healthcare

Basic Information

• Brand Name: Biotronix Healthcare
• Primary DI: 00850005165033
• Version / Model: URHT18
• Catalog Number: URHT18
• Company Name: BIOTRONIX HEALTHCARE INDUSTRIES, INC.
• Labeler DUNS: 065762392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-04
• Public Version: 2
• Public Version Date: 2019-12-24
• Public Version Status: Update
• Public Device Record Key: 6ee9d560-21ad-4da6-ab30-d6c60f70ef03

Device Description

Irrigation Tray with Bulb Syringe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	880.6960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63449	Wound irrigation kit, non-sterile	A collection of non-sterile devices intended to be used to irrigate/cleanse an acute or chronic external wound. It consists of multiple items which typically include an irrigation instrument (e.g., syringe, bulb), wipes, towel, drape and/or irrigation solution. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850005165030	GS1	Case	20	In Commercial Distribution
Primary	00850005165033	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Irrigation Tray with Bulb Syringe