Identity
- Trade Name
- ARGUS PB-3000 FDA UDI
- Generic Name
- Patient monitoring system module, multifunction FDA UDI
- Device Name
- The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data. FDA UDI
- Model / Reference
- PB-3000 Var.2, sub-variant: SAG FDA UDI
- Description
- The ARGUS PB-3000 is a vital data acquisition unit intended to be used within or connected to a medical device or a medical System (Host System) for acquiring, analysing, and transmission of patient vitals and other pertinent clinical data. FDA UDI
Identifiers
- Catalog Number
- 3.921001 FDA UDI
- Primary DI / UDI-DI
- 07613365001709 FDA UDI
- 510(k) Number
- K221056 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-3000 by Schiller Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K221056 also covers:
- ARGUS PB-3000 — Schiller Corp.
- Schiller CO2 connecting cable — Schiller Corp.
- Schiller CO2 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.
- Schiller ECG trunk cable — Schiller Corp.
- Schiller ECG trunk cable — Schiller Corp.
- Schiller ECG trunk 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 22e61adc-4789-42c2-9d02-54274f683964 37 fields · synced May 30, 2026