Catalog Number

82289801

Brand Name

BETACONNECT

Version/Model Number

82289801

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

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

-

FDA Premarket Submission

-

Product Code

KZH

Product Code Name

Introducer, Syringe Needle

Public Device Record Key

761886b5-14c7-41bb-8958-1547f5e06510

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

October 07, 2019

Package DI Number

05713495000022

Quantity per Package

10

Contains DI Package

05713495000015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-