Catalog Number

AC216

Brand Name

ICU Medical

Version/Model Number

AC216

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

K964435,K964435

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

453823ac-f16b-4b7d-8908-7c45566dde54

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

10840619082526

Quantity per Package

50

Contains DI Package

00840619082529

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS