Identity
- Trade Name
- NICaS FDA UDI
- Generic Name
- Impedance cardiograph FDA UDI
- Device Name
- Bioimpedance Cardiac Analyzing Measuring System FDA UDI
- Model / Reference
- CS FDA UDI
- Description
- Bioimpedance Cardiac Analyzing Measuring System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290015331005 FDA UDI
- 510(k) Number
- K080941 FDA UDI
- FDA Product Code
- DSB FDA UDI
- GMDN Term
- Impedance cardiograph FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2770 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
No
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
Category: Impedance cardiograph
NICaS by New N.i. Medical (2011) Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- ICG Module(Package/no accessory) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- PhysioFlow — MANATEC · 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
- New N.i. Medical (2011) Ltd
Sources (1)
- FDA UDI 1cbb66a0-6ea4-4706-b0eb-a6c95cbe0448 34 fields · synced Jun 1, 2026