Catalog Number

07313-01

Brand Name

ICU Medical

Version/Model Number

07313-01

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

K791796,K791796,K791796

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

d2cd5211-f371-4737-b4e9-8c3f2fbe3909

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

Package DI Number

20887709123643

Quantity per Package

1000

Contains DI Package

10887709123646

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case