FDA.report

Skytron warming cabinet

Primary DI
10841736111908
Brand
Skytron warming cabinet
Company
SKYTRON LLC
Model
W1-753021
Device description
Warming cabinet, 1 compartment, 3 adjustable shelves, digital controls with lockout and USB data ret
Published
2020-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications

CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841736111908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1084173611190810841736111908

GMDN Terms

TermDefinition
Multi-purpose warming cabinet, mobileA 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.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature-40 Degrees Fahrenheit159 Degrees Fahrenheit

Sterilization Methods

Method

Contacts

PhoneEmail
800-759-8766info@skytron.us

Regulatory Flags

DUNS number
078375583
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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