AccessGUDID - DEVICE: Skytron warming cabinet (10841736111946)

GUDID

Device Identifier (DI) Information

Brand Name: Skytron warming cabinet
Version or Model: W2-653021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SKYTRON LLC

Primary DI Number: 10841736111946
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078375583 *Terms of Use

Device Description: Warming cabinet, 2 compartment, 3 adjustable shelves, digital controls with lockout and USB data ret

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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
33512	Multi-purpose warming cabinet, mobile	A mains electricity (AC-powered) mobile 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 equipped with wheels that is designed to be wheeled (moved) from one location to another within a building complex. 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: No 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
Storage Environment Atmospheric Pressure: between 14 and 31.3 Inches of Mercury
Storage Environment Atmospheric Pressure: between 10 and 100 Percent (%) Relative Humidity
Storage Environment Temperature: between -40 and 159 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d6715698-7201-43ba-840d-3b3af7db69a8
Public Version Date: May 08, 2020
Public Version Number: 1
DI Record Publish Date: April 30, 2020