CPAP Tubing 100' Coil 22mm Tube with 6" Segments - CPAP Tubing 100' Coil 22mm Tube with 6" Segments - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: CPAP Tubing 100' Coil 22mm Tube with 6" Segments

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More Product Details

Catalog Number

TUB100-6

Brand Name

CPAP Tubing 100' Coil 22mm Tube with 6" Segments

Version/Model Number

TUB100-6

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

b5639874-34f6-49a4-ae9c-dc93d6368cbc

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

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