Identity
- Trade Name
- B-Smart FDA UDI
- Generic Name
- Nerve-block injection manometer FDA UDI
- Device Name
- B-Smart nerve-block injection pressure manometer FDA UDI
- Model / Reference
- BS015-30 FDA UDI
- Description
- B-Smart nerve-block injection pressure manometer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18053676290014 FDA UDI
- 510(k) Number
- K031128 FDA UDI
- FDA Product Code
- CAZ FDA UDI
- GMDN Term
- Nerve-block injection manometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5140 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nerve-block injection manometer
B-Smart by Hmc Premedical Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nerve-block injection manometer.
- NerveGuard — Pajunk GmbH Medizintechnologie · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Hmc Premedical Spa
Sources (1)
- FDA UDI a957963e-5fc8-449a-96ac-c5bfc471a933 35 fields · synced May 31, 2026