Catalog Number

Not Applicable

Brand Name

MedSource Extension Set

Version/Model Number

IT0360-PL

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

K120424,K120424,K120424

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

c39618c5-645e-4645-827e-6286b8d1636e

Public Version Date

February 04, 2022

Public Version Number

1

DI Record Publish Date

January 27, 2022

Package DI Number

00840155412323

Quantity per Package

20

Contains DI Package

00840155412316

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box