Suction Catheter - 12Fr, Y-Valve, Straight, Calibrated - Suction Catheter - 12Fr, Y-Valve, Straight, - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Suction Catheter - 12Fr, Y-Valve, Straight, Calibrated (1/pack)

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More Product Details

Catalog Number

TRASC112S

Brand Name

Suction Catheter - 12Fr, Y-Valve, Straight, Calibrated

Version/Model Number

TRASC112S

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

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Device Record Status

Public Device Record Key

2cc2c26d-1bb0-4aef-b145-154cdd4ff431

Public Version Date

April 20, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

20848530081984

Quantity per Package

10

Contains DI Package

10848530081987

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