Catalog Number

H-PFOL-40

Brand Name

Parker Flex-Tip

Version/Model Number

H-PFOL-40

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

-

Product Code

BTR

Product Code Name

Tube, Tracheal (W/Wo Connector)

Public Device Record Key

8f8f99f7-1756-472e-816c-9216e5807a5a

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

December 15, 2016

Package DI Number

50749065841405

Quantity per Package

10

Contains DI Package

30749065841401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case