Catalog Number

-

Brand Name

UNBRANDED

Version/Model Number

10-110

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Public Device Record Key

c0cdaa67-62b9-4d84-94f1-6df564f0e2ea

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2016

Package DI Number

10848340000048

Quantity per Package

50

Contains DI Package

00848340000041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-