3/16in Suction Tubing — 20in - 3/16in Suction Tubing — 20in - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: 3/16in Suction Tubing — 20in

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More Product Details

Catalog Number

RES025-31620

Brand Name

3/16in Suction Tubing — 20in

Version/Model Number

RES025-31620

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"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

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

BZD

Product Code Name

Ventilator, Non-Continuous (Respirator)

Device Record Status

Public Device Record Key

2d0fab18-af3a-4fd4-960c-b7fd77de1a62

Public Version Date

June 25, 2018

Public Version Number

1

DI Record Publish Date

May 25, 2018

Additional Identifiers

Package DI Number

10848530089020

Quantity per Package

10

Contains DI Package

00848530089023

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