**Pressure Line** Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with - **Pressure Line** Sunset Healthcare Durable CPAP - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: **Pressure Line** Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs **Pressure Line** Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with 22mm Cuffs Gray

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More Product Details

Catalog Number

TUB006PP

Brand Name

**Pressure Line** Sunset Healthcare Durable CPAP Tubing 6 Foot 19mm I.D. with

Version/Model Number

TUB006PP

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

023a9934-d154-4d86-be76-19b5e66a7446

Public Version Date

October 22, 2018

Public Version Number

1

DI Record Publish Date

September 19, 2018

Additional Identifiers

Package DI Number

10848530070172

Quantity per Package

50

Contains DI Package

00848530070175

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