Catalog Number

418000537

Brand Name

6" introducerStand alone, complementary accessory (to be used with ACT

Version/Model Number

418000537

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

K061409,K061409,K061409

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

5ce03817-7217-4744-bfa7-61994b68ee8c

Public Version Date

August 13, 2018

Public Version Number

1

DI Record Publish Date

July 13, 2018

Package DI Number

05707480111206

Quantity per Package

5

Contains DI Package

05707480111190

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-