Smithworks Medical, Inc.

Basic Information

• Brand Name: Smithworks Medical, Inc.
• Primary DI: B96412VSS3L02
• Version / Model: 12VSS3L02
• Company Name: Smithworks, Inc.
• Labeler DUNS: 009796074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-08
• Public Version: 1
• Public Version Date: 2024-04-16
• Public Version Status: New
• Public Device Record Key: cb6d7bad-c75b-4875-b7d7-39556da48842

Device Description

Soft Sack IV fluid warmer

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: 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: No
• 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
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66194	Intravenous fluid storage/warming bag	An electrically-powered device in the form of an insulated bag designed to store intravenous (IV) infusion bags and heat the IV solutions they contain to near body temperature before infusion; it is typically intended for use in an ambulance. It includes pouches to place the IV infusion bags, a heated metallic insert, and a temperature controller.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B96412VSS3L02	HIBCC