FDA.reportPublic FDA data

C-Warmer

Primary DI
08800017900094
Brand
C-Warmer
Company
DXM CO., LTD
Model
Blue
Device description
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.
Published
2023-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EFCWarmer, Anesthetic Tube

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFCWarmer, Anesthetic TubeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800017900094PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800017900094088000179000948800017900094

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia warmerA mains electricity (AC-powered) heating device into which tubes containing anaesthetic solutions are placed intended to warm the solution prior to it being administered to a patient for anaesthesia. It typically consists of a tabletop device that has wells for the anaesthetic solution tubes, a heating element, a thermostat and operating controls. It is designed to be portable for use in different locations where anaesthesia is administered.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature-10 Degrees Celsius85 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688797315
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800017901640CybirdULTRA2026-04-21
08800017902289EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902296EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017902302EZ BITE BLOCK SOFT MOUTH PROP BBS-5000M2025-12-18
08800017902319EZ BITE BLOCK SOFT MOUTH PROP BBS-6000L2025-12-18
08800017901817EZ Bite blockBB-3000M2025-12-16
08800017900605EZ Bite blockBB-3000M2025-12-16
08800017902203DX-Mixer1802025-09-29
08800017902265DX-Mixer1802025-09-29
08800017900223DX-CondenserSet2024-07-15
08800017901930C-WarmerDual2024-07-15
08800017902043Disposable Impression Bite TraySide/Posterior[BT-1000]2024-06-11
08800017902074Disposable Impression Bite TraySideless[BT-2000]2024-06-11
08800017902050Disposable Impression Bite TraySide/Posterior[BT-1000]2024-06-11
08800017902067Disposable Impression Bite TraySideless[BT-2000]2024-06-11
08800017902098Disposable Impression Bite TrayQuadrant[BT-3000]2024-06-11
08800017901923DX-Mixer1302024-06-04
08800017901978DX-Mixer1202024-06-04
08800017902005DX-Mixer1502024-06-04
08800017902029DX-Mixer2102024-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800017901930C-WarmerDXM CO., LTDEFC2024-07-15
E22190021Caps WarmerVOCO GmbHEFC2024-05-07
08800017900087C-WarmerDXM CO., LTDEFC2023-06-19
08800017900100C-WarmerDXM CO., LTDEFC2023-06-19
08800017900117C-WarmerDXM CO., LTDEFC2023-06-19
E22190031Caps WarmerVOCO GmbHEFC2021-02-02
E22160631VisCalor bulkVOCO GmbHEFC2019-05-10
E22190011Caps WarmerVOCO GmbHEFC2017-12-21
D8691100000AdDentADDENT, INC.EFC2017-06-01
00300361100037Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-20
10300361100034Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-20
00300361100020Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-14
10300361100027Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-14
00300361100013Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-01
10300361100010Pharmaceutical InnovationsPHARMACEUTICAL INNOVATIONS INCEFC2016-09-01