HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00810132041518
• Version / Model: HCS0911-50
• Company Name: Concordance Healthcare Solutions LLC
• Labeler DUNS: 080220245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: 2dcc48b5-04eb-47ab-b1d0-8661531fdcb9

Device Description

Bulb Irrigation Syringe, 50cc, Latex Free, Sterile

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• 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
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10810132041515	GS1		50	In Commercial Distribution
Primary	00810132041518	GS1