Duns Number:195055769
Device Description: The On Site Gas Systems portable oxygen generator is a prescription device designed to pro The On Site Gas Systems portable oxygen generator is a prescription device designed to provide an inexpensive supply of supplemental oxygen in a military environment without a continuous source of oxygen.
Catalog Number
-
Brand Name
POGS
Version/Model Number
POGS10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021082
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
14e5506e-653e-4376-9ccf-ff199a2de680
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
June 19, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |