Health Care Logistics, Inc®

Basic Information

• Brand Name: Health Care Logistics, Inc®
• Primary DI: 10827989007700
• Version / Model: 19389
• Company Name: Health Care Logistics, Inc.
• Labeler DUNS: 092159383
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-13
• Public Version: 2
• Public Version Date: 2025-05-01
• Public Version Status: Update
• Public Device Record Key: 2508c0bc-7094-4084-8462-4da0d3f540d2

Device Description

Enema Bottles and Tips, 4oz, PET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
FCE	Enema Kit	Gastroenterology, Urology	876.5210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61094	Rectal irrigation kit	A collection of devices that includes a rectal irrigation nozzle (also known as a catheter) intended to be used as part of a rectal irrigation system for the introduction of a non-medicated solution (typically water) into the rectum for patients affected by faecal incontinence or constipation; it is not intended for colostomy site irrigation or irrigation of the entire colon. In addition to the disposable nozzle, it includes a reusable fluid container (e.g., water bag). It is intended for use in the home and healthcare facility. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10827989007700	GS1

Customer Contacts

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