Extended CGA 540 Style Regulator, 0-15 LPM, with Long Stem - Extended CGA 540 Style Regulator, 0-15 LPM, with - SUNSET HEALTHCARE SOLUTIONS, INC.

Duns Number:141668116

Device Description: Extended CGA 540 Style Regulator, 0-15 LPM, with Long Stem

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More Product Details

Catalog Number

RES045L

Brand Name

Extended CGA 540 Style Regulator, 0-15 LPM, with Long Stem

Version/Model Number

RES045L

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

CAN

Product Code Name

Regulator, Pressure, Gas Cylinder

Device Record Status

Public Device Record Key

f79e5e4b-0061-43ae-a1ab-88037b36bc69

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

September 21, 2018

Additional Identifiers

Package DI Number

10848530087477

Quantity per Package

20

Contains DI Package

00848530087470

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