Identity
- Trade Name
- 2ST200-100 LuMon™ Monitor FDA UDI
- Generic Name
- Thoracic electrical impedance system, tomographic FDA UDI
- Device Name
- The LuMon™ Monitor is a noninvasive, non-radiological monitoring device that provides an assessment of regional impedance variation within a cross-section of a patient's thorax using an electrical impedance measuring device (LuMon™ Connector 2.0), an electrode belt (LuMon™ Belt) and a contact medium (LuMon™ Contact Gel). FDA UDI
- Model / Reference
- 2ST200-100 FDA UDI
- Description
- The LuMon™ Monitor is a noninvasive, non-radiological monitoring device that provides an assessment of regional impedance variation within a cross-section of a patient's thorax using an electrical impedance measuring device (LuMon™ Connector 2.0), an electrode belt (LuMon™ Belt) and a contact medium (LuMon™ Contact Gel). FDA UDI
Identifiers
- Primary DI / UDI-DI
- EIT12ST2001000 FDA UDI
- 510(k) Number
- K243765 FDA UDI
- FDA Product Code
- BZQ FDA UDIQEB FDA UDI
- GMDN Term
- Thoracic electrical impedance system, tomographic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2375 FDA UDI868.1505 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Thoracic electrical impedance system, tomographic
2ST200-100 LuMon™ Monitor by Sentec, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thoracic electrical impedance system, tomographic.
- ENLIGHT 1810 — Timpel S/A · Class II
- ENLIGHT 2100 — Timpel S/A · Class II
- ENLIGHT 2100 — Timpel S/A · Class II
- 1ST283-100 LuMon™ Belt Size 92 — Sentec, Inc. · Class II
- 1ST120-100 LuMon™ Connector 2.0 — Sentec, Inc. · Class II
- 1ST272-100 LuMon™ Belt Size 19 — Sentec, Inc. · Class II
- 1ST285-100 LuMon™ Belt Size 116 — Sentec, Inc. · Class II
- 1ST282-100 LuMon™ Belt Size 80 — Sentec, Inc. · Class II
Cleared under the same submission
K243765 also covers:
- 103583 LuMon™ Contact Gel Kit — Sentec, Inc.
- 1ST120-100 LuMon™ Connector 2.0 — Sentec, Inc.
- 1ST272-100 LuMon™ Belt Size 19 — Sentec, Inc.
- 1ST273-100 LuMon™ Belt Size 22 — Sentec, Inc.
- 1ST274-100 LuMon™ Belt Size 26 — Sentec, Inc.
- 1ST275-100 LuMon™ Belt Size 30 — Sentec, Inc.
- 1ST276-100 LuMon™ Belt Size 35 — Sentec, Inc.
- 1ST277-100 LuMon™ Belt Size 40 — Sentec, Inc.
- 1ST278-100 LuMon™ Belt Size 47 — Sentec, Inc.
- 1ST282-100 LuMon™ Belt Size 80 — Sentec, Inc.
- 1ST283-100 LuMon™ Belt Size 92 — Sentec, Inc.
- 1ST284-100 LuMon™ Belt Size 104 — Sentec, Inc.
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
- Sentec, Inc.
Sources (1)
- FDA UDI 0e27fc50-d7f8-44b8-818b-23b1c1d53542 34 fields · synced May 30, 2026