DEVICE: VELA (10190752153455)

Device Identifier (DI) Information

VELA
16532-12
Not in Commercial Distribution
16532-12
VYAIRE MEDICAL, INC.
10190752153455
GS1
October 14, 2024
1
080456871 *Terms of Use
VELA COMP CF,DISS,GRN O2,TYPE K,ICON OVERLAY
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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?
42411 Neonatal/adult intensive-care ventilator
A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).
Active false
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FDA Product Code

[?]
Product Code Product Code Name
CBK Ventilator, continuous, facility use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K093094 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
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

787204c9-a8a2-47a5-ba5a-6f03dba263e8
October 15, 2024
2
March 29, 2021
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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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

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No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(833)327-3284
customersupport@vyaire.com
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