Catalog Number

2B8071

Brand Name

VIAL-MATE

Version/Model Number

2B8071

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

K142600,K142600,K142600

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

0b95dafa-5ca6-43a5-93f2-4aafbed94890

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

50085412027383

Quantity per Package

200

Contains DI Package

20085412027382

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE