Sunset Adult Soft Cannula with 4ft Supply Tube - High Flow - Sunset Adult Soft Cannula with 4ft Supply Tube - - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Sunset Adult Soft Cannula with 4ft Supply Tube - High Flow

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More Product Details

Catalog Number

RES1104SHF

Brand Name

Sunset Adult Soft Cannula with 4ft Supply Tube - High Flow

Version/Model Number

RES1104SHF

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

CAT

Product Code Name

Cannula, Nasal, Oxygen

Device Record Status

Public Device Record Key

fe509dc2-6bea-4e09-b0e0-451f4ea2c69c

Public Version Date

March 22, 2022

Public Version Number

2

DI Record Publish Date

January 17, 2019

Additional Identifiers

Package DI Number

10848530089693

Quantity per Package

25

Contains DI Package

00848530089696

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