FDA UDI
In Commercial Distribution
🇺🇸 United States
Caps Warmer
DI: E22190021
·
Model: 9002
·
VOCO GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Caps Warmer
- Primary DI
- E22190021
- Version / Model
- 9002
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-07
- Public Version
- 1
- Public Version Date
- 2024-05-15
- Public Version Status
- New
- Public Device Record Key
- 398b4b8a-556b-4fc5-a618-db08c7fa0c3e
Device Description
Device for temporary heating of dental composites in order to improve application properties.
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
- Yes
- 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 |
| EEG | Heat Source For Bleaching Teeth | Dental | 872.6475 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | Dental | 872.6070 | 2 |
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 | E22190021 | HIBCC |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]