SOBERLINK
- Primary DI
- B90107
- Brand
- SOBERLINK
- Company
- SOBERLINK HEALTHCARE LLC
- Model
- SOBERLINK LTE REFURB- 07
- Published
- 2021-12-08
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- true
- Sterile
- false
- Single use
- false
Product Codes#
Code, Name table| Code | Name |
|---|
| DJZ | Devices, Breath Trapping, Alcohol |
Product Code Classifications#
Code, Device, Specialty table| Code | Device | Specialty | Class |
|---|
| DJZ | Devices, Breath Trapping, Alcohol | Clinical Toxicology | 1 |
Identifiers And Packaging#
Identifier, Type, Agency table| Identifier | Type | Agency | Package quantity | Status |
|---|
| B90107 | Primary | HIBCC | 0 | |
GMDN Terms#
Term, Definition table| Term | Definition |
|---|
| Alcohol breath analyser | A portable, battery-powered instrument intended to measure and document alcohol concentrations in human breath at the point-of-care. |
Regulatory Flags#
- DUNS number
- 079871438
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
Primary DI, Brand, Model table| Primary DI | Brand | Model | Catalog | Published |
|---|
| B90112 | SOBERLINK | SOBERLINK 7.0 | | 2025-08-19 |
| B90105 | SOBERLINK | SOBERLINK GSM1 REFURB - 05 | | 2021-04-07 |
| B90110 | SOBERLINK | SOBERLINK CELLULAR CATM | | 2023-09-23 |
| B90111 | SOBERLINK | SOBERLINK CELLULAR CATM REFURB | | 2023-09-23 |
| B90108 | SOBERLINK | SOBERLINK CONNECT ST - 08 | | 2022-06-23 |
| B90109 | SOBERLINK | SOBERLINK Connect ST REFURB | | 2022-06-23 |
| B90106 | SOBERLINK | SOBERLINK LTE - 06 | | 2021-12-08 |
| B90101 | SOBERLINK | SOBERLINK Connect - 01 | | 2021-04-07 |
| B90102 | SOBERLINK | SOBERLINK GSM2 - 02 | | 2021-04-07 |
| B90103 | SOBERLINK | SOBERLINK Connect REFURB - 03 | | 2021-04-07 |
| B90104 | SOBERLINK | SOBERLINK GSM2 REFURB - 04 | | 2021-04-07 |
| B901CONNECT0 | SOBERLINK | CONNECT | | 2020-05-07 |
| B901CONNECTREFURB0 | SOBERLINK | SOBERLINK CONNECT REFURB | | 2020-05-07 |
| B901GSM1REFURB0 | SOBERLINK | SOBERLINK GSM1 REFURB | | 2020-05-07 |
| B901GSM20 | SOBERLINK | SOBERLINK GSM2 | | 2020-05-07 |
| B901GSM2REFURB0 | SOBERLINK | SOBERLINK GSM2 REFURB | | 2020-05-07 |
Other Devices Sharing Product Codes#