Cylinder Roller Bag & Backpack — Single D/E Tank - Cylinder Roller Bag & Backpack — Single D/E Tank - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Cylinder Roller Bag & Backpack — Single D/E Tank

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More Product Details

Catalog Number

CSBD1Roller

Brand Name

Cylinder Roller Bag & Backpack — Single D/E Tank

Version/Model Number

CSBD1Roller

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

9d6259cd-b0f2-4536-aac1-71b3f76a9cad

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

10848530087781

Quantity per Package

8

Contains DI Package

00848530087784

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