FDA UDI
In Commercial Distribution
🇺🇸 United States
A/T 2000 XR Intraoral Film Processor with Water Recirculation System
DI: D678450040
·
Model: 45004
·
AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- A/T 2000 XR Intraoral Film Processor with Water Recirculation System
- Primary DI
- D678450040
- Version / Model
- 45004
- Company Name
- AIR TECHNIQUES, INC.
- Labeler DUNS
- 043835081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- fb155152-f60c-45d9-a1f8-01e7524b35ee
Device Description
A/T 2000 XR Intraoral Film Processor with Water Recirculation System provides high quality radiographs in any size such as Panoramic, Cephalometric, TMJ, Occlusal and all Intraorals. Includes: 1 levelling base, 1 bottle spray 2000 Plus; 4 Air Techniques cleaning films; 1 instructional DVD: 1 case chemistry, 1 bottle of starter, and 2 1/2 gallon water container.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| IXW | Processor, Radiographic-Film, Automatic | Radiology | 892.1900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15939 | Dental automated x-ray film processor | A mains electricity (AC-powered) automated dental x-ray film processor designed to be used in the dental practise for the rapid processing of films. This x-ray film processing system will automatically develop, fix, wash, and dry dental x-ray film. It is typically of floor or desktop design. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D678450040 | HIBCC | ||||
| Package | D678450041 | HIBCC | box | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-800-247-8324
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001321 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 75 | Pound | |
| Depth | 26 | Inch | |
| Width | 14.25 | Inch | |
| Height | 15 | Inch |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 60 Degrees Celsius