DEVICE: AirLife™ (10190752114937)
Device Identifier (DI) Information
AirLife™
002446
In Commercial Distribution
002446
VYAIRE MEDICAL, INC.
002446
In Commercial Distribution
002446
VYAIRE MEDICAL, INC.
AirLife™ Misty Max 10™ Nebulizer With 7 foot (2.1 m) Female U/Connect-It Crush Resistant Oxygen Tubing, Baffled Tee Adapter (22 mm I.D./ 22 mm O.D.), Mouthpiece and 6 inch (15 cm) Flextube
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
35457 | Benchtop nebulizer, non-heated |
An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAF | Nebulizer (direct patient interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
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
789cf29b-253b-4ff6-a074-d994b4adce63
June 10, 2022
2
January 15, 2020
June 10, 2022
2
January 15, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
50190752114935 | 50 | 10190752114937 | In Commercial Distribution | Case |
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