FDA UDI
In Commercial Distribution
🇺🇸 United States
AlcoMate
DI: 00853464001409
·
Model: SM3100
·
AK Globaltech Corp
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- AlcoMate
- Primary DI
- 00853464001409
- Version / Model
- SM3100
- Catalog Number
- AKG-SM3100
- Company Name
- AK Globaltech Corp
- Labeler DUNS
- 119201320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-10-06
- Public Version
- 3
- Public Version Date
- 2023-06-09
- Public Version Status
- Update
- Public Device Record Key
- 00c0bd01-b7be-41b0-98b4-dff433617166
Device Description
Fuel-Cell technology provides you with increased precision and accuracy, and also less worry with maintenance, since fuel-cell alcohol sensor modules are rated to at least 1000 tests before needing replacement. Fuel-Cell Sensor Modules should be replaced approximately every 1000 tests, or at least once yearly.
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
- No
- 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 |
|---|---|---|---|---|
| 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 | 00853464001409 | GS1 |
Customer Contacts
- Phone
- 201-943-9411
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Special Storage Condition, Specify: Proper storage includes avoidance of temperatures beyond operating range (10-40 degrees Celsius), and avoidance of moisture.