AccessGUDID - DEVICE: AVEA (10190752177048)

GUDID

Device Identifier (DI) Information

Brand Name: AVEA
Version or Model: 51000-40043
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 51000-40043
Company Name: VYAIRE MEDICAL, INC.

Primary DI Number: 10190752177048
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080456871 *Terms of Use

Device Description: FLOW SENSOR,INSPIRATORY ASSEMBLY

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):	No
Over the Counter (OTC):	No
Kit:	No
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?
38489	Uninterruptible power supply	A portable device, commonly known as an uninterruptible power supply (UPS), designed to provide a continuous supply of electrical power for a limited period of time to a connected device or devices during the failure of the mains electricity (AC-power) supply due to an emergency situation, e.g., a blackout, or maintenance/testing. It will contain its own set of batteries that normally maintain their charge from the mains power supply and it is these that provide the power when a failure in the line-power occurs. This device is used locally (at the point of use) and is often reserved to supply vital devices, e.g., ventilators, patient monitoring devices and computer dependent devices.	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: 41985c39-30a6-4131-bf2f-98d2a61408db
Public Version Date: May 17, 2021
Public Version Number: 1
DI Record Publish Date: May 07, 2021

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)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(833)327-3284
Email: customersupport@vyaire.com

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