Flex O2 Bag - Flex O2 Bag - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Flex O2 Bag

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More Product Details

Catalog Number

CSBM6Flex

Brand Name

Flex O2 Bag

Version/Model Number

CSBM6Flex

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

CCX

Product Code Name

Support, Patient Position

Device Record Status

Public Device Record Key

de506942-cbbf-4517-896c-8d40e6110eb7

Public Version Date

April 21, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2018

Additional Identifiers

Package DI Number

10848530081949

Quantity per Package

50

Contains DI Package

00848530081942

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