Catalog Number

220582

Brand Name

MediBag

Version/Model Number

220582

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

7d60613e-71fd-4a9b-89c1-79305d61f192

Public Version Date

June 18, 2021

Public Version Number

1

DI Record Publish Date

June 10, 2021

Package DI Number

10850000509235

Quantity per Package

30

Contains DI Package

00850000509238

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-