← Back to catalogue
Fogg Patient Monitoring Cable
EUDAMEDFDA UDIFDA 510(k)Class I (EU MDR)
Ref 0264-2049
Identity
- Trade Name
- FOGG SYSTEM COMPANY, INC. FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- Fogg Patient Monitoring Cable EUDAMED0264-2049 Interface Cable FDA UDI
- Model / Reference
- 0264-2049 EUDAMEDFDA UDI
- Description
- 0264-2049 Interface Cable FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840416601039 EUDAMEDFDA UDI
- Basic UDI-DI
- 8404166CBL001G7 EUDAMED
- Direct Marketing DI
- 00840416601039 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
- Austria 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
Fogg Patient Monitoring Cable by Fogg System Company, Inc. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222712 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 8404166CBL001G7 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fogg System Company, Inc.
- EUDAMED SRN
- US-MF-000040329
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED 2eaa02f3-13b7-42f3-9081-13f7b7088b2b 61 fields · synced Oct 6, 2026
- FDA UDI 6fa0efa7-3e9c-47c7-99bf-b7404b7d3e7d 35 fields · synced May 29, 2026
- FDA 510(k) K222712 1 fields · synced May 18, 2026