3.0 Liter Disposable Set

Basic Information

• Brand Name: 3.0 Liter Disposable Set
• Primary DI: 00896128002534
• Version / Model: 903-00032
• Company Name: BELMONT INSTRUMENT CORPORATION
• Labeler DUNS: 078330362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-11-08
• Public Version Status: Update
• Public Device Record Key: 4c0eaff0-d9d6-47ad-a97f-f274f4eecb00

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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	880.5725	2
FRN	Pump, Infusion	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41609	Heat-exchanging intravenous administration set	A collection of noninvasive devices designed to directly warm and conduct fluids from an intravenous (IV) administration bag/bottle to a peripheral venous cannula (not included) during gravitational or pump administration to a patient's venous system. It typically includes tubing, connectors, chambers, and clamps; the bag/bottle may be included. It does not include devices intended to be used invasively. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896128002534	GS1

Premarket Submissions

Submission Number	Supplement Number
K141654	000