POGS - The Portable Oxygen Generator System 33 (POGS - ON SITE GAS SYSTEMS, INC.

Duns Number:195055769

Device Description: The Portable Oxygen Generator System 33 (POGS 33C) has been designed to accommodate medica The Portable Oxygen Generator System 33 (POGS 33C) has been designed to accommodate medical personnel with a source of supplemental oxygen in a setting where liquid oxygen may be unavailable, and of medical air to drive respiratory equipment.

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More Product Details

Catalog Number

-

Brand Name

POGS

Version/Model Number

POGS33C

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

K063454

Product Code Details

Product Code

CAW

Product Code Name

Generator, Oxygen, Portable

Device Record Status

Public Device Record Key

bd1f5670-a0a1-4a54-9069-c81813805b60

Public Version Date

April 20, 2020

Public Version Number

2

DI Record Publish Date

June 19, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ON SITE GAS SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2