FDA UDI
In Commercial Distribution
🇺🇸 United States
C-Warmer
DI: 08800017900094
·
Model: Blue
·
DXM CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- C-Warmer
- Primary DI
- 08800017900094
- Version / Model
- Blue
- Company Name
- DXM CO., LTD
- Labeler DUNS
- 688797315
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-19
- Public Version
- 1
- Public Version Date
- 2023-06-27
- Public Version Status
- New
- Public Device Record Key
- 13eac08f-0cd9-4ec0-9594-0193ce626720
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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EFC | Warmer, Anesthetic Tube | Dental | 872.6100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31810 | Anaesthesia warmer | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08800017900094 | GS1 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 85 Degrees Celsius