Identity
- Trade Name
- 0395-2454 Interface Cable EUDAMEDFOGG SYSTEM COMPANY, INC. FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Fogg Patient Monitoring Cable EUDAMED0395-2454 Interface Cable FDA UDI
- Model / Reference
- 0395-2454 EUDAMEDFDA UDI
- Description
- 0395-2454 Interface Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840416600322 EUDAMEDFDA UDI
- Basic UDI-DI
- 8404166CBL001G7 EUDAMED
- Direct Marketing DI
- 00840416600322 EUDAMED
- 510(k) Number
- K222712 FDA UDI
- FDA Product Code
- DSA FDA UDI
- EMDN Code
- Z1203020280 MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2900 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
0395-2454 Interface Cable by Fogg System Company, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8404166CBL001G7 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Fogg System Company, Inc.
- EUDAMED SRN
- US-MF-000040329
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (2)
- EUDAMED 24db5d7f-1814-4fc8-958a-fa9885041771 61 fields · synced Jul 16, 2026
- FDA UDI 1ef9f36a-ed1e-4c50-9cdb-8c3e1b409ba0 35 fields · synced May 30, 2026