Level 1

Basic Information

• Brand Name: Level 1
• Primary DI: 50695085828264
• Version / Model: H-1100-ES-115V
• Company Name: SMITHS MEDICAL MD, INC.
• Labeler DUNS: 106712748
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-14
• Public Version: 4
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: f7b0faa1-d193-463c-8e38-130d5a34ad8d

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
47621	Convection blood/fluid warmer, high-flow	An electrically-powered device designed for in-line heating of rapidly-infused (may exceed 1 L/min) banked blood, blood products, and intravenous (IV) solutions (crystalloid and colloid), typically from about 4ºC to near body temperature (i.e., 35 to 37ºC), during high-blood-loss surgical procedures and for burn and trauma cases. The device usually includes an aqueous heat exchanger (e.g., water bath) for the convection of heat to the infusion blood/fluid via a disposable set (e.g., coiled tubing); it also includes temperature controls and/or alarms. It is typically mounted on an IV pole under the infusion bag; it does not infuse blood/fluid.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	50695085828264	GS1