FDA.reportPublic FDA data

AdDent

Primary DI
D8691100000
Brand
AdDent
Company
ADDENT, INC.
Model
Calset
Catalog number
110000
Device description
Calset warmer for composite materials/anaesthesia and instruments.
Published
2017-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
D8691100000PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2037780200dpinto@addent.com

Regulatory Flags#

DUNS number
099490679
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8691300001AdDentCompex HD1300002026-04-22
D86911008001AdDentMicrolux 21100802017-06-01
D8691120010AdDentOraBlu1120012017-06-01
D86962000706AdDentMicrolux6200072017-06-01
D86911009002AdDentBio/Screen1100902017-06-01

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
08800017900094C-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
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