Catalog Number

68215

Brand Name

NA

Version/Model Number

68215

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 2021

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

K030888,K030888

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

25eb857a-0e40-4c3f-b1f7-ec927f1bc125

Public Version Date

April 07, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

50812496011423

Quantity per Package

50

Contains DI Package

00812496011428

Package Discontinue Date

April 06, 2021

Package Status

Not in Commercial Distribution

Package Type

Cardboard Carton