Identity
- Trade Name
- SOBERLINK FDA UDI
- Generic Name
- Alcohol breath analyser FDA UDI
- Model / Reference
- SOBERLINK GSM1 REFURB - 05 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B90105 FDA UDI
- 510(k) Number
- K160613 FDA UDI
- FDA Product Code
- DJZ FDA UDI
- GMDN Term
- Alcohol breath analyser FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Soberlink by Soberlink Healthcare, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Soberlink Healthcare, LLC
Sources (1)
- FDA UDI e810b03c-094d-4a41-8776-5f7809157878 34 fields · synced Jun 6, 2026