FDA UDI
In Commercial Distribution
🇺🇸 United States
AlcoMate
DI: 00853464001355
·
Model: AlcoMate Revo TS200
·
AK Globaltech Corp
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AlcoMate
- Primary DI
- 00853464001355
- Version / Model
- AlcoMate Revo TS200
- Catalog Number
- AKG TS200
- Company Name
- AK Globaltech Corp
- Labeler DUNS
- 119201320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-24
- Public Version
- 3
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- 19014ebb-c21b-4233-a555-25f2aad2ec98
Device Description
The AlcoMate Revo breathalyzer combines the revolutionary innovation of PRISM technology with state-of-the-art fuel-cell precision to offer the most reliable, convenient and accurate commercial breathalyzer available on the market. PRISM Technology, Advanced Fuel-Cell Alcohol Sensor, Sleek, Lightweight Design, Single-source Selection by the US Navy and Marine Corps.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OIC | Blood Alcohol Kit (Excludes Hiv Testing) | Clinical Toxicology | 862.3040 | 2 |
| DJZ | Devices, Breath Trapping, Alcohol | Clinical Toxicology | 862.3050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36041 | Alcohol breath analyser | A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853464001355 | GS1 |
Customer Contacts
- Phone
- 201-943-9411
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit