Catalog Number

26475

Brand Name

EXEL BLUNT TIP ALUMINUM STERILE HUB NEEDLE

Version/Model Number

26475

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

K101309,K101309,K101309,K101309

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

99c41765-eecc-410e-af24-4ab8d9acacb3

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

July 16, 2019

Package DI Number

30020221264754

Quantity per Package

10

Contains DI Package

20020221264757

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton