Device
13.5 CU FT STAINLESS COMBINATION WARMER FREESTANDING 120VAC TYPE-B CORD WINDOW LEFT HAND DOORS WITH FEET ENTHERMICS BRANDED
Manufacturer
PEDIGO PRODUCTS, INC.
PEDIGO PRODUCTS, INC.
Model: EC1350BL-LH
DI: 00841027104759
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-12
Current Version: 2026-05-20
Description
13.5 CU FT STAINLESS COMBINATION WARMER FREESTANDING 120VAC TYPE-B CORD WINDOW LEFT HAND DOORS WITH FEET ENTHERMICS BRANDED
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
02c0afc1-238e-487b-980e-5f9f2c8d1543
Distribution Status:
In Commercial Distribution
DUNS Number:
008301772
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
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:
00841027104759
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
Premarket Submissions
Submission Number:
K132202
Supplement Number:
000