Device
Laboratory Refrigerator, 18 cu ft
Manufacturer
HELMER, INC.
Model: iLR118-GXC DI: 00816394021947 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: No OTC: No
First Published: 2026-05-13 Current Version: 2026-05-21
Description
Laboratory Refrigerator, 18 cu ft
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 0e90dca3-eb6b-4c78-b20d-42f66b910b2f
Distribution Status: In Commercial Distribution
DUNS Number: 086685682
Device Count: 1
DM Exempt: No
Premarket Exempt: Yes
HCT/P: No
Kit: No
Combination Product: No
Lot/Batch Tracked: No
Serial Number Tracked: Yes
Manufacturing Date Tracked: Yes
Expiration Date Tracked: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00816394021947
Type: Primary
Issuing Agency: GS1
GMDN
Code: 17157
Name: Laboratory refrigerator, basic
Definition:
A mains electricity (AC-powered) refrigerator specially designed to maintain the cold temperatures required for the storage of samples, specimens, cultures, and other laboratory preparations. It will typically have a corrosion resistant (e.g., stainless steel) interior to minimize the risk of adulteration, contamination, and/or corrosion of contents; include a glass door and internal shelving for easy set-up of instrumentation and chromatography devices within the chamber. It will typically include sensors, controls and monitors, forced-air circulation and a built-in alarm system that warns against unexpected temperature variations as well as a recorder to record events.
FDA Product Codes
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use