AccessGUDID - DEVICE: Warming Cabinet Single Compartment Counter-Top Model (Glass Door) (07540162040092)

GUDID

Device Identifier (DI) Information

Brand Name: Warming Cabinet Single Compartment Counter-Top Model (Glass Door)
Version or Model: OR-8154
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OR-8154
Company Name: Imperial Surgical Ltd

Primary DI Number: 07540162040092
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 245253575 *Terms of Use

Device Description: Warming Cabinet Single Compartment Counter-Top Model (Glass Door) / 29" x 26" x 34", 7.2 CU. FT/PI3

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
40516	Multi-purpose warming cabinet, stationary	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, Thermal, Infusion Fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store ina cool dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35298ccf-1649-48c9-9fd9-d26abf479af4
Public Version Date: September 06, 2023
Public Version Number: 1
DI Record Publish Date: August 29, 2023