DEVICE: Medic (04719875322082)

Device Identifier (DI) Information

Medic
M-OA-FH01
In Commercial Distribution

MEDIC TRADE CO., LTD.
04719875322082
GS1

1
656820797 *Terms of Use
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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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?
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).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IRQ Unit, Heating, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
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 Record Status

9f1e9f6b-da6e-4932-a378-67a2e24f7397
June 02, 2023
2
March 30, 2023
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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
14719875322089 1 04719875322082 In Commercial Distribution
24719875322086 4 14719875322089 In Commercial Distribution
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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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 3602324119
sales@innotechmedical.com
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