DEVICE: Medic (04719875322082)
Device Identifier (DI) Information
Medic
M-OA-FH01
In Commercial Distribution
MEDIC TRADE CO., LTD.
M-OA-FH01
In Commercial Distribution
MEDIC TRADE CO., LTD.
The Expiratory Filter Heater is designed to warm the surface of a filter used in the expiratory pathway of a breathing circuit. The device is intended to prolong filter efficiency by minimizing excessive condensation that can cause expiratory resistance. Adding a heated filtration system to a ventilator can also protect the exhalation system and currounding environment from contamination which prevents the spread of infectious diseases. The heater consists of an aluminum heating surface that is thermostatically controlled to maintain an ideal temperature.
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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61736 | Breathing circuit condenser |
A portable, mains electricity (AC-powered) device designed to be integrated within the expiratory limb of a ventilator breathing circuit to remove excess moisture through cooling and condensing, whilst also reheating the dried gases to an appropriate ventilator-compatible temperature. It includes a heat exchanger and may include disposable condensate collection devices (e.g., cartridge, collection bag). It is intended to prevent condensation from forming within the expiratory limb and ventilator (rain-out).
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FDA Product Code
[?]Product Code | Product Code Name |
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IRQ | Unit, Heating, Powered |
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
9f1e9f6b-da6e-4932-a378-67a2e24f7397
June 02, 2023
2
March 30, 2023
June 02, 2023
2
March 30, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14719875322089 | 1 | 04719875322082 | In Commercial Distribution | ||
24719875322086 | 4 | 14719875322089 | In Commercial Distribution |
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
[?]
+1 3602324119
sales@innotechmedical.com
sales@innotechmedical.com