DEVICE: Vyaire (14250892904402)
Device Identifier (DI) Information
Vyaire
36-MTH6410
In Commercial Distribution
36-MTH6410
Jaeger Medical GmbH
36-MTH6410
In Commercial Distribution
36-MTH6410
Jaeger Medical GmbH
Rubber Flanged Mouthpiece
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? |
---|---|---|---|---|
43467 | Breathing mouthpiece, reusable |
A device designed for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system. It is typically a small rigid or semi-rigid hollow device with a shape and structure that enables an appropriate gastight seal and prevents collapse. The device accepts or attaches to, either directly or through other tubes/adapters, diagnostic/therapeutic respiratory devices (e.g., ventilator, inhaler, incentive spirometer, aerosol equipment, breath analyser). Some types generate a whistling sound to guide effective inhalation [e.g., during use of a metered dose inhaler (MDI)]. This is a reusable device which may be intended for single- or multi-patient use.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BYP | Mouthpiece, Breathing |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3df5ccd7-db48-40ed-ba2c-9cb23749c913
May 28, 2025
7
March 19, 2019
May 28, 2025
7
March 19, 2019
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+499314972127
support.rt.eu@vyaire.com
support.rt.eu@vyaire.com