Catalog Number

-

Brand Name

DUALGUARD ADULT 10FT LINE WITH FEMALE LUER LOCK

Version/Model Number

032-10-850U

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)

Yes

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

K140473

Product Code

CAT

Product Code Name

Cannula, Nasal, Oxygen

Public Device Record Key

22b75904-886b-442f-a5bd-a89e918bc2dc

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

October 04, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-