AMSure® Cleansing Enema Set

Basic Information

• Brand Name: AMSure® Cleansing Enema Set
• Primary DI: 10704411008378
• Version / Model: 1
• Catalog Number: AS330
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-05
• Public Version: 1
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: d690f5d9-29e0-43c8-bab6-929694422247

Device Description

AMSure® Cleansing Enema Set CONTENTS: 1, One (1) each 1500 mL Enema Bag: -Pre-lubricated Tip - Tubing Clamp 2, Moisture Proof Drape 3, Enema Soap Packet

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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	40704411008379	GS1	case	50	In Commercial Distribution
Primary	10704411008378	GS1