6Ft Light Gray Smoothbore CPAP Tubing - Slim Style - 6Ft Light Gray Smoothbore CPAP Tubing - Slim Style - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: 6Ft Light Gray Smoothbore CPAP Tubing - Slim Style

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More Product Details

Catalog Number

TUB006SS

Brand Name

6Ft Light Gray Smoothbore CPAP Tubing - Slim Style

Version/Model Number

TUB006SS

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

-

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

BZO

Product Code Name

Set, Tubing And Support, Ventilator (W Harness)

Device Record Status

Public Device Record Key

913cb1dc-4f77-4f05-8ab0-652850266c26

Public Version Date

October 26, 2018

Public Version Number

1

DI Record Publish Date

September 25, 2018

Additional Identifiers

Package DI Number

10848530070387

Quantity per Package

50

Contains DI Package

00848530070380

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