Disposable MRI Kit with Check Valve - Spectris MR Injector Kit (Includes: (2) 65 ML - BAYER MEDICAL CARE INC.

Duns Number:058716649

Device Description: Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing Spectris MR Injector Kit (Includes: (2) 65 ML Front Load syringes, 96" low pressure tubing with an integrated check valve, 1 large spike for loading saline, 1 small spike(MR - SPECTRIS SYRINGE KIT, 2-65ML, CV)(60728532)

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More Product Details

Catalog Number

SQK 65VS

Brand Name

Disposable MRI Kit with Check Valve

Version/Model Number

SQK 65VS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

LNH

Product Code Name

System, Nuclear Magnetic Resonance Imaging

Device Record Status

Public Device Record Key

e047dea3-dc4f-49e7-ade4-f5f7d18d540d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

10616258005444

Quantity per Package

50

Contains DI Package

00616258005447

Package Discontinue Date

December 31, 9999

Package Status

In Commercial Distribution

Package Type

-

"BAYER MEDICAL CARE INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 360