Catalog Number

48653

Brand Name

Halyard

Version/Model Number

48653

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

f8e3c8d1-b706-485c-ab50-6bcb947e0714

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

December 17, 2021

Package DI Number

20680651486534

Quantity per Package

1

Contains DI Package

10680651486537

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP