MRI ECG Cable - MRI ECG Cable - IVY BIOMEDICAL SYSTEMS, INC.

Duns Number:109132019

Device Description: MRI ECG Cable

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More Product Details

Catalog Number

-

Brand Name

MRI ECG Cable

Version/Model Number

3725-02-01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

69505bdf-3d0b-4603-a074-136e9b314e4d

Public Version Date

October 14, 2022

Public Version Number

1

DI Record Publish Date

October 06, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"IVY BIOMEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 216