Catalog Number

PAT-06

Brand Name

AlliedSil™ Silicone Tubing

Version/Model Number

PAT-06

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"

-

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

K955433

Product Code

KGZ

Product Code Name

Accessories, Catheter

Public Device Record Key

5e33a490-6e4a-4b95-b590-85f7762c0a41

Public Version Date

June 08, 2021

Public Version Number

6

DI Record Publish Date

July 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-