DEVICE: Anapod Breathing Circuit (00709078008887)

Device Identifier (DI) Information

Anapod Breathing Circuit
A9243
Not in Commercial Distribution

WESTMED, INC.
00709078008887
GS1
May 17, 2024
1
092673953 *Terms of Use
Anapod Humi-Therm Heated and Humidified Wick Breathing Circuit, 48" Heated Humidified Transport Circuit, 48" Expiratory Limb
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Device Characteristics

Labeling does not contain MRI Safety Information
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Yes
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GMDN

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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?
60966 Respiratory gas heating wire, adult
A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
BZE Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K904538 000
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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

9d24dedc-d185-4a2a-96c6-9a13fae7b356
May 17, 2024
3
July 31, 2020
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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
10709078008884 10 00709078008887 2024-05-17 Not in Commercial Distribution Case
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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