Catalog Number

MB4V01

Brand Name

AMSafe® MicroClave® multi-Dose vial Access spike

Version/Model Number

1

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

K081361,K081361

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

a55cfdd7-8a0b-42d3-a36e-e509117c3a5a

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

September 23, 2016

Package DI Number

40704411004517

Quantity per Package

50

Contains DI Package

10704411004516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case