Identity
- Trade Name
- ICG Module(Package/no accessory) FDA UDI
- Generic Name
- Impedance cardiograph FDA UDI
- Model / Reference
- 115-013197-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904085807 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Impedance cardiograph 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Impedance cardiograph
ICG Module(Package/no accessory) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Impedance cardiograph.
- PhysioFlow — MANATEC · Class II
- BLUEMED — BLUEMED · Class II
- NICaS — NEW N.I. MEDICAL (2011) LTD · Class II
- Bodyport Cardiac Scale — Bodyport, Inc. · Class II
- PhysioFlow — MANATEC · Class II
- PhysioFlow — MANATEC · Class II
- ICG module (w accessory kit) — Shenzhen Mindray Bio-Medical Electronics Co. · 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
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 04332e45-0605-4449-93cc-b5f7f5594f3f 33 fields · synced Jun 6, 2026