Catalog Number

-

Brand Name

Vial2Bag Advanced 20mm

Version/Model Number

6070030

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"

-

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

K201415,K201415,K201415

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

f654a494-5cfd-4548-b013-c5dd74b880e0

Public Version Date

December 31, 2020

Public Version Number

1

DI Record Publish Date

December 23, 2020

Package DI Number

20850022888018

Quantity per Package

50

Contains DI Package

10850022888011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Intermediate Box