FDA UDI
In Commercial Distribution
🇺🇸 United States
AlcoBreath Tube
DI: G354AAB08201
·
Model: ABT08
·
Alcopro Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25
Basic Information
- Brand Name
- AlcoBreath Tube
- Primary DI
- G354AAB08201
- Version / Model
- ABT08
- Catalog Number
- AAB0820
- Company Name
- Alcopro Inc.
- Labeler DUNS
- 113044739
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-09-22
- Public Version
- 1
- Public Version Date
- 2022-09-30
- Public Version Status
- New
- Public Device Record Key
- 4b730cce-073d-4426-9a85-207d1d8f3f05
Device Description
Disposable breath alcohol test
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | G354AAB08202 | HIBCC | 100 | In Commercial Distribution | ||
| Primary | G354AAB08201 | HIBCC | ||||
| Unit of Use | G354AAB08200 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102225 | 000 |