Catalog Number

220121

Brand Name

MediBag

Version/Model Number

220121

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

K001287,K001287,K001287

Product Code

KPE

Product Code Name

Container, I.V.

Public Device Record Key

687601b0-c708-475d-a499-0478bbff2f8f

Public Version Date

October 07, 2019

Public Version Number

6

DI Record Publish Date

September 09, 2016

Package DI Number

20857595005118

Quantity per Package

60

Contains DI Package

10857595005111

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-