Catalog Number

323487

Brand Name

BD Home Sharps Collector

Version/Model Number

323487

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K943139,K943139

Product Code

FMI

Product Code Name

Needle, hypodermic, single lumen

Public Device Record Key

113aba7a-3ff0-4b21-98e6-0188c7022126

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 03, 2016

Package DI Number

50382903234870

Quantity per Package

12

Contains DI Package

00382903234875

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case