Device
Pharmacy Refrigerator, 20 cu ft
Manufacturer
HELMER, INC.
Model: iPR120-GXC DI: 00816394022012 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
Pharmacy Refrigerator, 20 cu ft
Sterilization
Device Sterile: No
Sterilization Prior To Use: No
Regulatory & Distribution
Record Status: Published
Version Number: 1
Record Key: 8ba3f60d-2faf-44cb-a6a6-f97585b1c0dd
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: 00816394022012
Type: Primary
Issuing Agency: GS1
GMDN
Code: 17156
Name: Pharmacy refrigerator
Definition:
A mains electricity (AC-powered) refrigerator specially designed for cool storage of pharmaceuticals, e.g., medications or live virus vaccines. It may be provided with a built-in alarm system that warns against unexpected temperature variations.
FDA Product Codes
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use