Identity
- Trade Name
- TFC Fingersensor 150 MEDIUM FDA UDI
- Generic Name
- Multiparameter physiologic analysis workstation FDA UDI
- Model / Reference
- V4.x.y FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120073932969 FDA UDI
- 510(k) Number
- K223332 FDA UDI
- FDA Product Code
- DXN FDA UDI
- GMDN Term
- Multiparameter physiologic analysis workstation FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1130 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multiparameter physiologic analysis workstation
TFC Fingersensor 150 MEDIUM by CNSystems Medizintechnik GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223332 also covers:
- TFC Adapter Plate — CNSystems Medizintechnik GmbH
- TFC Armsling — CNSystems Medizintechnik GmbH
- TFC CNAP Classic Adapter — CNSystems Medizintechnik GmbH
- TFC Cable (2, 5m) — CNSystems Medizintechnik GmbH
- TFC Fingersensor 150 LARGE — CNSystems Medizintechnik GmbH
- TFC Fingersensor 150 SMALL — CNSystems Medizintechnik GmbH
- TFC Fingersensor 75 LARGE — CNSystems Medizintechnik GmbH
- TFC Fingersensor 75 MEDIUM — CNSystems Medizintechnik GmbH
- TFC Fingersensor 75 SMALL — CNSystems Medizintechnik GmbH
- TFC Forearm Controller — CNSystems Medizintechnik GmbH
- TFC Forearm Controller Clamp — CNSystems Medizintechnik GmbH
- TFC Forearm Controller Fixing Strap — CNSystems Medizintechnik GmbH
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
- CNSystems Medizintechnik GmbH
Sources (1)
- FDA UDI 94c07147-b83e-4ad0-9999-aed91931ade7 33 fields · synced May 30, 2026