Identity
- Trade Name
- 3C5A Ultrasonic Transducer V2.0 (I) FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- 120-000178-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904087146 FDA UDI
- 510(k) Number
- K120699 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
3C5A Ultrasonic Transducer V2.0 (I) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120699 also covers:
- 4D and TEE Driver Module Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- Battery Kit(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW kit — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-T6 Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-010 Needle-guided Bracket/VET — Shenzhen Mindray Bio-Medical Electronics Co.
- Pen Probe function materials(CW) — Shenzhen Mindray Bio-Medical Electronics Co.
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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 27966e82-cae3-407d-86a8-08dc1a5ddcb1 34 fields · synced Jun 1, 2026