MRI ECG Cable

FDA UDI

Class II (US FDA UDI)

by Ivy Biomedical Systems, Inc.

Identity

Trade Name: MRI ECG Cable FDA UDI
Generic Name: MRI system synchronizer FDA UDI
Device Name: MRI ECG Cable FDA UDI
Model / Reference: 3684-04-01 FDA UDI
Description: MRI ECG Cable FDA UDI

Identifiers

Primary DI / UDI-DI: 00816396022621 FDA UDI
FDA Product Code: MWI FDA UDI
LNH FDA UDI
GMDN Term: MRI system synchronizer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.2300 FDA UDI
892.1000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 24 Inch FDA UDI

Category: MRI system synchronizer

MRI ECG Cable by Ivy Biomedical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as MRI system synchronizer.

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MR Patient Care Universal Gating Interface — Philips DS North America LLC · Class II
Pneumograph - Non-Metallic 18' w/Connector — Lafayette Instrument Company · Class I
Pediatric Pneumograph - Non-Metallic w/10' Tubing — Lafayette Instrument Company · Class I
Pneumograph - Non-Metallic 12' w/Connector — Lafayette Instrument Company · Class I
Pneumograph Nonmetalic 135cm Strap — Lafayette Instrument Company · Class I
Pneumograph - Non-Metallic 89in. Tubing — Lafayette Instrument Company · Class I

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: Ivy Biomedical Systems, Inc.

Sources (1)

FDA UDI e40a4efd-f32c-4a43-8346-c356d8e62cb8 35 fields · synced Jun 9, 2026