Catalog Number

68125

Brand Name

NA

Version/Model Number

68125

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

K030888,K030888

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

5a2cea55-b4bb-446f-8541-46e90e8f6a1d

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50812496011379

Quantity per Package

50

Contains DI Package

00812496011374

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Cardboard Carton