FDA UDI
In Commercial Distribution
🇺🇸 United States
AirStar Clinical Air Compressor
DI: D678AS600
·
Model: AS60
·
AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- AirStar Clinical Air Compressor
- Primary DI
- D678AS600
- Version / Model
- AS60
- Company Name
- AIR TECHNIQUES, INC.
- Labeler DUNS
- 043835081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-14
- Public Version
- 1
- Public Version Date
- 2023-06-22
- Public Version Status
- New
- Public Device Record Key
- 81a151a7-c108-41d6-a0cb-3fc2b8199d57
Device Description
AirStar Clinical Air Compressor’s compressed air station is designed to supply compressed air in order to operate dental units or for similar applications. The compressed air station has been designed for operation in dry, ventilated rooms.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NRD | Unit, Operative Dental, Accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31253 | Medical device air compressor | A mains electricity (AC-powered) device designed to create compressed air and supply it directly to gas-powered or compressed air dependent devices (e.g., ventilators or other respiratory devices, laboratory equipment). It may also provide medical air depending upon the filtering systems employed. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D678AS601 | HIBCC | Box | 1 | In Commercial Distribution | |
| Primary | D678AS600 | HIBCC |
Customer Contacts
- Phone
- +1 (516) 214-5512
- [email protected]