CARDINAL HEALTH ESSENTIALS - Adult Tracheostomy Tube Holder - RGH ENTERPRISES

Duns Number:049735438

Device Description: Adult Tracheostomy Tube Holder

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More Product Details

Catalog Number

ZRTT240

Brand Name

CARDINAL HEALTH ESSENTIALS

Version/Model Number

ZRTT240

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Over the Counter (OTC)

Yes

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

480f9da8-89d6-4e0b-88d7-23032fe70bdb

Public Version Date

May 17, 2019

Public Version Number

1

DI Record Publish Date

May 09, 2019

Additional Identifiers

Package DI Number

00888499009427

Quantity per Package

10

Contains DI Package

00888499009410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"RGH ENTERPRISES" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 45
2 A medical device with a moderate to high risk that requires special controls. 1
U Unclassified 1