AccessGUDID - DEVICE: AirLife™ (10190752128651)

GUDID

Device Identifier (DI) Information

Brand Name: AirLife™
Version or Model: 16607
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 16607
Company Name: VYAIRE MEDICAL, INC.

Primary DI Number: 10190752128651
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: PEDIATRIC/ADULT AIRWAY ADAPTER

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:	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?
46820	Carbon dioxide cuvette, reusable	A device intended to be used with a mainstream carbon dioxide (CO2) sensor for the determination of CO2 concentration in gases expired from a patient. It is typically designed as a small, plastic, open-ended vessel with a clear optic window (cuvette) for the acceptance of an infrared sensor that is slotted over the outside of the window section. It typically has connector ports that enable it to be connected into a breathing system (e.g., an anaesthesia or critical care ventilation system). This is a reusable device.	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: 0622447b-989c-4548-8916-51b8756863da
Public Version Date: October 15, 2024
Public Version Number: 2
DI Record Publish Date: March 12, 2021