Catalog Number

PF 1515

Brand Name

PF 1515 Straight Silicone Rubber Connector

Version/Model Number

PF 1515

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

CAI

Product Code Name

Circuit, Breathing (W Connector, Adaptor, Y Piece)

Public Device Record Key

19c5608a-b524-4cdb-bcf8-c4df291d0272

Public Version Date

September 20, 2021

Public Version Number

1

DI Record Publish Date

September 10, 2021

Package DI Number

M996PF15152

Quantity per Package

10

Contains DI Package

M996PF15150

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ziplock Bag