Catalog Number

501P

Brand Name

Pedi Tie

Version/Model Number

501P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Public Device Record Key

75e51a12-6831-4890-87ac-8b5df61d5a04

Public Version Date

January 10, 2022

Public Version Number

2

DI Record Publish Date

April 17, 2020

Package DI Number

10850014574403

Quantity per Package

20

Contains DI Package

00850014574130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box