AMSure® Flat Top Piston Irrigation Syringe

Basic Information

• Brand Name: AMSure® Flat Top Piston Irrigation Syringe
• Primary DI: 10704411010159
• Version / Model: 1
• Catalog Number: AS115
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-15
• Public Version: 1
• Public Version Date: 2018-11-15
• Public Version Status: New
• Public Device Record Key: db662985-1549-4b4a-8f4f-08e29a996d7c

Device Description

AMSure® Flat Top Piston Irrigation Syringe Contents: • 1 Flat Top Piston Irrigation Syringe, 60ml/2oz • 1 Tip Protector • 1 Small Tube Adapter Caution: Proceed with irrigation procedure, using approved technique.

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: 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	40704411010150	GS1	case	50	In Commercial Distribution
Primary	10704411010159	GS1