Infusion Pouch 500mL

Basic Information

• Brand Name: Infusion Pouch 500mL
• Primary DI: 17290109153985
• Version / Model: 05080-605-0001
• Company Name: EITAN MEDICAL LTD
• Labeler DUNS: 533108028
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-06
• Public Version: 2
• Public Version Date: 2022-11-23
• Public Version Status: Update
• Public Device Record Key: 0066f50a-e2f5-498b-97a5-fb1094fd9515

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
MRZ	Accessories, Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36794	Infusion pump tester	A device assembly designed to assess the performance of infusion pumps by accurately measuring, evaluating, displaying, and/or recording a set of pump variables (typically output flow, volume delivery, and occlusion pressure needed to activate the pump alarms). The assembly usually consists of a computerized electronic unit, measuring devices (e.g., volume, flow, pressure, time), a display, and a recorder. It is used to test general-purpose, syringe, and/or ambulatory infusion pumps and may be operated manually or user programmable to run automatic test protocols. This device is intended to be used by a professional in a professional setting (e.g., clinical engineering).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	17290109153985	GS1