AccessGUDID - DEVICE: Vyaire (00819601021310)

GUDID

Device Identifier (DI) Information

Brand Name: Vyaire
Version or Model: Pulmonary Function Cal Gas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z04NI695EDC001
Company Name: AIRGAS USA LLC

Primary DI Number: 00819601021310
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 831996595 *Terms of Use

Device Description: Description: 0.27% CO, 9.7% He, 21% O2, Bal. N2; Cylinder: ED; Valve: CGA 973; For use with Vyaire's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; CE Marked; Vyaire Part #: 001-899140;

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?
35282	Pulmonary function analysis system, adult	A device used to measure the function of the respiratory system in adults and compliant children. It usually includes a spirometer with volume-sensing (e.g., rolling-seal, bellow) and flow-sensing (e.g., pneumotachometer) devices, a gas analyser for evaluation of absolute lung volumes and gas-diffusing capacity of the lungs, and computer capabilities for data processing and recording; a total-body plethysmograph to measure both lung volumes and airway resistance may be included. The device is mostly used for outpatient or presurgical screening, and may also be used in the diagnosis and evaluation of common diseases in older children [e.g., asthma, cystic fibrosis (CF), chest deformities].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BXK	Gas, Calibration (Specified Concentration)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: less than 52 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 459 Liter
Pressure: 1833 Pound per Square Inch

Device Record Status

Public Device Record Key: 385d5cb0-c854-43b5-b525-a93fc287ebd7
Public Version Date: January 08, 2020
Public Version Number: 1
DI Record Publish Date: December 31, 2019