FDA UDI
In Commercial Distribution
🇺🇸 United States
AIR-FLOW
DI: 07613353197162
·
Model: DV-164/A/MIN
·
E.M.S. Electro Medical Systems S.A.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
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Basic Information
- Brand Name
- AIR-FLOW
- Primary DI
- 07613353197162
- Version / Model
- DV-164/A/MIN
- Company Name
- E.M.S. Electro Medical Systems S.A.
- Labeler DUNS
- 481233849
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2019-12-13
- Public Version
- 2
- Public Version Date
- 2025-08-18
- Public Version Status
- Update
- Public Device Record Key
- 57df38d0-4fb9-474c-9b3b-9d3b82f9e440
Device Description
4 bottles 300g powder AIR-FLOW CLASSIC Mint
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJR | Agent, Polishing, Abrasive, Oral Cavity | Dental | 872.6030 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45407 | Professional dental abrasive material | A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613353197162 | GS1 | ||||
| Unit of Use | 07613353197216 | GS1 |
Customer Contacts
- Phone
- +41229944700
- [email protected]