Identity
- Trade Name
- CABLE,XDUCER,IBP,EDWARD,12PIN FDA UDI
- Generic Name
- Intracranial/compartmental-pressure monitor calibrator/cable FDA UDI
- Model / Reference
- 0010-21-12179 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904003856 FDA UDI
- 510(k) Number
- K143195 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Intracranial/compartmental-pressure monitor calibrator/cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Intracranial/compartmental-pressure monitor calibrator/cable
Cable, Xducer, Ibp, Edward, 12pin 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
K143195 also covers:
- 12-Lead Leadset, Chest, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 12-Lead Leadset, Chest, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Cable, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Cable, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead ECG Host Cable, Def-P — Shenzhen Mindray Bio-Medical Electronics Co.
- 12Pin 3-Lead Host Cable, Def-P, DIN Conn — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-LEAD, ECG, UNIV, SNAP, 18", USA — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-LEAD, ECG, UNIV, SNAP, 36", AAMI — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead Leadset, Adt/Ped, AHA, Clip — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead Leadset, Inf, AHA, Snap — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 24", AAMI — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 24", IEC — 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 0effc080-2859-4798-a3b6-13b7de45927b 34 fields · synced May 30, 2026