Rainbow Tie - Rainbow Trach Tie - PEPPER MEDICAL INC.

Duns Number:622637098

Device Description: Rainbow Trach Tie

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More Product Details

Catalog Number

301PRV

Brand Name

Rainbow Tie

Version/Model Number

301PRV

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CBH

Product Code Name

DEVICE, FIXATION, TRACHEAL TUBE

Device Record Status

Public Device Record Key

c70e512d-9888-40a4-a390-9517d8d3750f

Public Version Date

January 10, 2022

Public Version Number

2

DI Record Publish Date

April 17, 2020

Additional Identifiers

Package DI Number

10850014574380

Quantity per Package

10

Contains DI Package

00850014574307

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"PEPPER MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 49