Catalog Number

19003

Brand Name

TwoFer Needle

Version/Model Number

19003

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

K832347,K832347

Product Code

LHI

Product Code Name

Set, I.V. Fluid Transfer

Public Device Record Key

7d7a67d7-65a5-485d-af8b-101e8eac5847

Public Version Date

August 09, 2019

Public Version Number

4

DI Record Publish Date

December 01, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-