DEVICE: Rugged Oxygen Generator (ROG) (05060031380002)

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Device Identifier (DI) Information

Rugged Oxygen Generator (ROG)
EO209P63N29

MOLECULAR PRODUCTS LIMITED
05060031380002
GS1
1
The ROG is a chemical based portable oxygen generator which generates 99% oxygen for at least 15 minutes at a flow rate of at least 6 Lpm. It is a self-contained device with the oxygen delivered via standard oxygen face mask or nasal cannula.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Emergency oxygen production unit, reusable A portable, non-electric device designed to produce medical grade oxygen, from activated chemicals, to administer to patients in first aid or emergency situations (e.g., cardiac emergencies, asthma/COPD exacerbations, shock/ trauma in the field). It consists of a reusable housing with an activation button, a single-use breathing apparatus (e.g., mask/tubing), and a replaceable single-use oxygen-generating chemical cartridge. The device is intended to be used by healthcare professionals and laypersons. This is a reusable device upon replacement of single-use components.
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FDA Product Code

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Product Code Product Code Name
CAW Generator, Oxygen, Portable
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -20 and 50 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 26, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05060031380019 6 05060031380002 In Commercial Distribution Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
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None
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Production Identifier(s) in UDI

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Yes
No
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No CLOSE

Customer Contact

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+4401279445111
sales@molprod.com
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