AccessGUDID - DEVICE: AVEA (10190752159075)

GUDID

Device Identifier (DI) Information

Brand Name: AVEA
Version or Model: 12284-PMN
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 12284-PMN
Company Name: VYAIRE MEDICAL, INC.

Primary DI Number: 10190752159075
Issuing Agency: GS1
Commercial Distribution End Date: October 14, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080456871 *Terms of Use

Device Description: KIT, AVEA UPGRADE GDE & SOFTWARE

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36554	Patient monitoring system module, pulse oximetry	A small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.	Active	false
40582	Ventilator application software	An individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a ventilator. A basic set of applications programs and routines are included with the ventilator and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBK	Ventilator, continuous, facility use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103211	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 121c7ad6-c839-4600-86fe-7859de74d90b
Public Version Date: October 15, 2024
Public Version Number: 2
DI Record Publish Date: March 26, 2021