InfuseOne

Basic Information

• Brand Name: InfuseOne
• Primary DI: 10889483230787
• Version / Model: 42357-01H
• Catalog Number: 42357-01H
• Company Name: ETHOX MEDICAL, LLC
• Labeler DUNS: 079149179
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-01
• Public Version: 1
• Public Version Date: 2024-07-09
• Public Version Status: New
• Public Device Record Key: 76da910d-9beb-4d3c-8f72-33afd0acd6ae

Device Description

3000ml ICU Medical InfuseOne Pressure Infusion Bag

Device Characteristics

• Single Use: No
• 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: MR Conditional
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• 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
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	880.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13100	Intravenous pressure infusor, manual, reusable	A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20889483230784	GS1	Box	5	In Commercial Distribution
Primary	10889483230787	GS1
Package	30889483230781	GS1	Case	25	In Commercial Distribution

Customer Contacts

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