Catalog Number

48651

Brand Name

Halyard

Version/Model Number

48651

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

K183473,K183473,K183473,K183473

Product Code

NGT

Product Code Name

Saline, vascular access flush

Public Device Record Key

a7debdc2-c5fe-41da-a642-75e29f9ec338

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

December 17, 2021

Package DI Number

30680651486517

Quantity per Package

16

Contains DI Package

20680651486510

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS