Biotronix Healthcare Enema Bag Set

Basic Information

• Brand Name: Biotronix Healthcare Enema Bag Set
• Primary DI: 00850005165026
• Version / Model: GE41001
• Catalog Number: GE41001
• 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: c5f760db-b451-4903-a7a7-7393b241ef78

Device Description

Enema Bag Set

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
FCE	Enema Kit	Gastroenterology, Urology	876.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35050	Gravity enema set	A collection of devices intended to be used to deliver an injection of fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine. It includes a fluid reservoir (e.g., enema bag) which acts as a gravity-flow chamber, and typically includes enema tube(s) and enema tip; it may be prefilled with a non-medicated enema solution and may be available preassembled. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850005165023	GS1	Case	48	In Commercial Distribution
Primary	00850005165026	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Enema Bag Set