Catalog Number

H-PMLT-60

Brand Name

Parker Flex-Tip

Version/Model Number

H-PMLT-60

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

c6c21dbd-2c19-4d37-9270-7e413d38155b

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

October 27, 2015

Package DI Number

50749065181600

Quantity per Package

10

Contains DI Package

30749065181606

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case