DEVICE: EPIFLO® oxygen delivery cannula (00855526003024)

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Device Identifier (DI) Information

EPIFLO® oxygen delivery cannula
01-110-100002

Neogenix, LLC
00855526003024
GS1
1
Oxygen delivery cannula for use with EPIFLO device only.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Wound therapy oxygenator, single-use A wearable, battery-powered device designed to actively promote continuous diffusion of oxygen (CDO) in a wound to help heal various types of wounds (e.g., arterial, venous, diabetic or pressure ulcers; burns; postoperative or traumatic wounds). It is intended to concentrate oxygen (O2) from ambient air and pump it through an included sterile delivery tube intended to be secured to the wound bed, which is typically covered by an absorbent and occlusive dressing. It is intended to be used continuously over a prescribed period, being discarded and replaced along with the dressing as required. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KPJ Chamber, Oxygen, Topical, Extremity
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Sterilization

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

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Storage and Handling
No storage/handling found
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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
October 07, 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
No Package DIs found
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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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
2168390202
lcali@ogenix.com
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