Catalog Number

MB4BR07

Brand Name

AMSafe® 7 in. (18cm) Microbore Bifurcated Ext. Set

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

8a56f55f-1d26-4722-9fa7-03dd1f5d5b4b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 26, 2016

Package DI Number

40704411005668

Quantity per Package

50

Contains DI Package

10704411005667

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case