Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric - Tracheostomy Tube Neckband 2-Piece with Fastener - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric

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More Product Details

Catalog Number

RES030P

Brand Name

Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Pediatric

Version/Model Number

RES030P

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"

-

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

b7330bb7-bbf9-471b-ac13-f46f0c4ae890

Public Version Date

August 31, 2018

Public Version Number

1

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

10848530062245

Quantity per Package

20

Contains DI Package

00848530062248

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SUNSET HEALTHCARE SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 160
2 A medical device with a moderate to high risk that requires special controls. 68