Catalog Number

SQK 65VA

Brand Name

Disposable MRI Kit with Check Valve

Version/Model Number

SQK 65VA

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

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"

Yes

For Single-Use

Yes

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

K980417,K980417

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Public Device Record Key

9e65dac9-dce5-4874-b030-02ea480005e0

Public Version Date

November 04, 2019

Public Version Number

1

DI Record Publish Date

October 25, 2019

Package DI Number

40616258021568

Quantity per Package

50

Contains DI Package

00616258021560

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-