FDA UDI
In Commercial Distribution
🇺🇸 United States
AlcoMate
DI: 00853464001102
·
Model: Premium AL7000
·
AK Globaltech Corp
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AlcoMate
- Primary DI
- 00853464001102
- Version / Model
- Premium AL7000
- Catalog Number
- AKG AL7000
- 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
- c12129c5-8d45-47be-ad9c-f62a90a78c0a
Device Description
The AlcoMate Premium breathalyzer features patented PRISM Technology, which eliminates two fundamental flaws of traditional re-calibration: sensor degradation and the turnaround cycle. The Premium is approved by the US Department of Transportation (DOT) for law enforcement use, and is widely used by both professionals and general consumers concerned with long-term accuracy. The US Navy selected the AlcoMate brand for single-source supply for its ongoing substance testing program.
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 | 00853464001102 | GS1 |
Customer Contacts
- Phone
- 201-943-9411
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 50 – 104 Degrees Fahrenheit