Identity
- Trade Name
- ARGUS® PB-2000 FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- The ARGUS® PB-2000 parameter box is acquiring and monitoring patient’s vital parameters such as invasive blood pressure (IBP), temperature, CO2, and SpO2. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-2000. This data is then transmitted to the visualization unit via a serial interface. FDA UDI
- Model / Reference
- 3.920983 FDA UDI
- Description
- The ARGUS® PB-2000 parameter box is acquiring and monitoring patient’s vital parameters such as invasive blood pressure (IBP), temperature, CO2, and SpO2. All vital parameters and evaluations are registered and calculated in the ARGUS® PB-2000. This data is then transmitted to the visualization unit via a serial interface. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613365000191 FDA UDI
- 510(k) Number
- K012226 FDA UDI
- FDA Product Code
- MHX FDA UDI
- GMDN Term
- Patient monitoring system module, multifunction 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, multifunction
Argus® Pb-2000 by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient monitoring system module, multifunction.
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- Avalon TOCO+ Transducer — Philips Medizin Systeme Böblingen GmbH · Class II
- MPM Module (with MR ECG, NIBP, Temp) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- SOMNOscreen plus PSG+ Tele Camera Compact AASM Set — Somnomedics GmbH
- IBP_CO_SidestreamCO2 module(FDA/PK.) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Benelink module package(FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K012226 also covers:
- ARGUS® PB-1000 — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller Cardiac output connecting cable — Schiller Corp.
- Schiller ECG extension wires — Schiller Corp.
- Schiller ECG extension wires — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
- Schiller ECG patient cable — Schiller Corp.
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
- Schiller Corp.
Sources (1)
- FDA UDI 1e60e342-58d4-4180-a47f-e77152bc65b4 36 fields · synced May 30, 2026