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0386-2110 Interface Cable

EUDAMEDFDA UDI

Class I (EU MDR)

Ref 0386-2110

by Fogg System Company, Inc.

Identity

Trade Name
0386-2110 Interface Cable EUDAMED
FOGG SYSTEM COMPANY, INC. FDA UDI
Generic Name
Electrical-only medical device connection cable, reusable FDA UDI
Device Name
Fogg Patient Monitoring Cable EUDAMED
0386-2110 Interface Cable FDA UDI
Model / Reference
0386-2110 EUDAMEDFDA UDI
Description
0386-2110 Interface Cable FDA UDI

Identifiers

Primary DI / UDI-DI
00840416605280 EUDAMEDFDA UDI
Basic UDI-DI
8404166CBL001G7 EUDAMED
Direct Marketing DI
00840416605280 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 EUDAMED
Class 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
MRI Safety
MR Unsafe FDA UDI

The Fogg Patient Monitoring Cable, part of the comprehensive Interface Cable series from MedEnvoy Global BV, is a cutting-edge solution designed to enhance patient monitoring and care. This cable features advanced data transfer capabilities, ensuring secure and reliable communication between medical devices and networks. By providing a seamless interface for various medical purposes, it plays a vital role in improving healthcare outcomes.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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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 bf795c7d-29ef-48dc-839b-107f79c60320 61 fields · synced Oct 6, 2026
  • FDA UDI 174a64ba-e21f-41b1-abd9-91f0cf80ebdd 35 fields · synced May 30, 2026