Model: OR-9000-FBLK
DI: 07540162042867
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
db8781c9-a5f9-4b65-9a10-a98573794d31
Distribution Status:
In Commercial Distribution
DUNS Number:
245253575
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:
07540162042867
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 40516
Name: Multi-purpose warming cabinet, stationary
Definition:
A mains electricity (AC-powered) device designed to warm various items and products prior to use, e.g., bags of irrigation or intravenous (IV) solutions, blankets or clothing to cover or put onto a patient, or clothing for the operating room (OR) personnel to adorn. It typically consists of a heat insulated enclosure with a sealing door, shelves, heating element(s), a thermostat and operating controls. This is a freestanding cabinet (tabletop or floor design) that is designed to be stationary and used in one location. It may also be used in a laboratory.
FDA Product Codes
LGZ
Warmer, Thermal, Infusion Fluid