C-Warmer

GUDID 08800017900100

C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled cartridge/composite warmer significantly reduces curing time with more flowability of composites and conveniently warms anesthetics and composites in one locations.

DXM CO., LTD

Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer Anaesthesia warmer
Primary Device ID08800017900100
NIH Device Record Key825329f4-61e8-427f-82ef-baf5830974a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameC-Warmer
Version Model NumberBlue Type 1
Company DUNS688797315
Company NameDXM CO., LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -10 Degrees Celsius and 85 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108800017900100 [Primary]

FDA Product Code

EFCWarmer, Anesthetic Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-27
Device Publish Date2023-06-19

On-Brand Devices [C-Warmer]

08800017900117C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled
08800017900100C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled
08800017900094C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled
08800017900087C-Warmer is designed to enhance both the doctor' and the patiends'. A themostatically-controlled

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