DEVICE: Passive Heated Breathing Circuit Kit (00848530104153)
Device Identifier (DI) Information
Passive Heated Breathing Circuit Kit
VC1114-KIT
In Commercial Distribution
SUNSET HEALTHCARE SOLUTIONS, INC.
VC1114-KIT
In Commercial Distribution
SUNSET HEALTHCARE SOLUTIONS, INC.
(1) Adult Single Limb Passive Heated Wire Circuit - Fisher & Paykel OEM # RT114 with (1) Swivel Exhalation Port for Ventilator Circuits & CPAP (Comparable to Respironics 332113)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
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
f7479b1a-0bbc-4995-878b-b9b035decd3c
June 07, 2024
1
May 30, 2024
June 07, 2024
1
May 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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
877-578-6738
customerservice@sunsethcs.com
customerservice@sunsethcs.com