Humidifier Tubing Connector with Tube 21" - Humidifier Tubing Connector with Tube 21" - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Humidifier Tubing Connector with Tube 21"

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More Product Details

Catalog Number

HUM008L

Brand Name

Humidifier Tubing Connector with Tube 21"

Version/Model Number

HUM008L

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

BYX

Product Code Name

Tubing, Pressure And Accessories

Device Record Status

Public Device Record Key

650a69b0-6164-4984-9590-ace2ddea18e8

Public Version Date

October 18, 2018

Public Version Number

1

DI Record Publish Date

September 17, 2018

Additional Identifiers

Package DI Number

20848530086255

Quantity per Package

20

Contains DI Package

10848530086258

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