DEVICE: Amron Oxygen Treatment Hood (00860010778616)
Device Identifier (DI) Information
Amron Oxygen Treatment Hood
8891-03
In Commercial Distribution
Amron International, Inc.
8891-03
In Commercial Distribution
Amron International, Inc.
02 VINYL HOOD W/OPTICAL WINDOW, NECK RING ASSEMBLY, UNTRIMMED SILICONE NECK SEAL
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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45543 | Oxygen administration hood, adult |
A device consisting of a rigid transparent plastic shell forming an enclosure over the head of an adult, typically to provide an enriched oxygen (O2)environment to increase the patient's O2 uptake. It is connected to an O2 source and may be used concurrently with increased humidification and temperature control. It is designed for a variety of situations: 1) for those adverse to oxygen delivery devices such as a nasal cannula or face mask; 2) for use inside hyperbaric chambers; 3) for specific pulmonary testing. It may include the tubing, a diffuser (to disperse the flow of incoming O2), O2 concentration and humidity sensors, and audio listening facilities. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FOG | Hood, Oxygen, Infant |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
0f324e9b-f277-4e00-b6e2-5aebfbc659f2
January 07, 2025
1
December 30, 2024
January 07, 2025
1
December 30, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
7602086589
dlynch@amronintl.com
dlynch@amronintl.com