DEVICE: 3100A HFOV (10190752201576)
Device Identifier (DI) Information
3100A HFOV
770630-101
In Commercial Distribution
770630-101
VYAIRE MEDICAL, INC.
770630-101
In Commercial Distribution
770630-101
VYAIRE MEDICAL, INC.
3100A DISPOSABLES SHIP KIT (RIGID CIRCUIT)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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37706 | Ventilator breathing circuit, single-use |
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LSZ | VENTILATOR, HIGH FREQUENCY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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P890057 | 000 |
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
ed3a9af5-bd4e-4179-9d69-07d426aa19f2
August 20, 2024
1
August 12, 2024
August 20, 2024
1
August 12, 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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(833)327-3284
customersupport@vyaire.com
customersupport@vyaire.com