Catalog Number

KN-2138RB

Brand Name

K-Pack II

Version/Model Number

KN-2138RB

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

K984576,K984576

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

3402c2ae-7bb4-4a10-9948-7bb5e8911f04

Public Version Date

October 27, 2022

Public Version Number

6

DI Record Publish Date

September 05, 2016

Package DI Number

55413206018142

Quantity per Package

5000

Contains DI Package

05413206018147

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton