Essential MRI Patient Monitor (Model 865353) - Essential MRI Patient Vital Signs Monitor for - INVIVO CORPORATION

Duns Number:013649151

Device Description: Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI

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More Product Details

Catalog Number

865353

Brand Name

Essential MRI Patient Monitor (Model 865353)

Version/Model Number

Essential MRI Patient Monitor

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)

Yes

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

DQA

Product Code Name

Oximeter

Device Record Status

Public Device Record Key

4f150e79-c944-4209-bfb8-494e42d544a6

Public Version Date

March 09, 2022

Public Version Number

5

DI Record Publish Date

September 30, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INVIVO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 17
2 A medical device with a moderate to high risk that requires special controls. 650
U Unclassified 4