Unifusors

Basic Information

• Brand Name: Unifusors
• Primary DI: 10841522128097
• Version / Model: Unifusors
• Catalog Number: 999T
• Company Name: STATCORP MEDICAL
• Labeler DUNS: 038942055
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-20
• Public Version: 5
• Public Version Date: 2023-08-18
• Public Version Status: Update
• Public Device Record Key: 73b5e843-9fab-402b-884d-159d38a1530b

Device Description

UNIFUSOR II,INFLATION SET,PISTON,THUMBWHEEL,EA

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: 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: 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
Primary	10841522128097	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius