DEVICE: O2asis Humidifier (00840106905447)

Device Identifier (DI) Information

O2asis Humidifier
O2asis Cannula Adult
In Commercial Distribution

PERMA PURE LLC
00840106905447
GS1

1
063142533 *Terms of Use
O2asis Cannula Adult Replacement consumable for the O2asis Humidifier
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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?
12050 Heated respiratory humidifier
A mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K193411 000
No CLOSE

Sterilization

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

[?]
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 Record Status

4b7e79e0-62c1-4dd7-82c0-01a128a87448
June 15, 2023
1
June 07, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
00810020360721 2 00840106905447 In Commercial Distribution Inner Pack
00810020360806 5 00840106905447 In Commercial Distribution Inner Pack
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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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
866-334-2447
permapureqc@permapure.com
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