Catalog Number

456065

Brand Name

MRVLS LB 2V GXL BLS

Version/Model Number

Large Bore MRVLS Stopcock

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

K060231,K190489,K060231,K190489,K060231,K190489

Product Code

FMG

Product Code Name

Stopcock, I.V. Set

Public Device Record Key

6d80e993-23d2-4a69-88f5-9f48821882eb

Public Version Date

June 09, 2020

Public Version Number

1

DI Record Publish Date

June 01, 2020

Package DI Number

17290102590084

Quantity per Package

100

Contains DI Package

07290102590087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box