Catalog Number

44-4100

Brand Name

Halyard

Version/Model Number

46641

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

-

Product Code

PIF

Product Code Name

Gastrointestinal Tubes with Enteral Specific Connectors

Public Device Record Key

e6130bf6-1587-4143-9031-dce7b4a7b5df

Public Version Date

October 23, 2019

Public Version Number

4

DI Record Publish Date

October 24, 2017

Package DI Number

30680651466410

Quantity per Package

30

Contains DI Package

10680651466416

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS