AccessGUDID - DEVICE: Bionostic, Inc. (00819601025226)

GUDID

Device Identifier (DI) Information

Brand Name: Bionostic, Inc.
Version or Model: Calibration Gas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z03NI5143000000
Company Name: Airgas Therapeutics, LLC

Primary DI Number: 00819601025226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118537769 *Terms of Use

Device Description: Description: 0.70% CO2, 48% O2, BAL. N2; Cylinder: 300; Valve: CGA 296; For calibration of medical analyzers in accordance with manufacturer's instructions.

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?
65332	Calibration gas/refillable cylinder	A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, refillable, cylindrical container intended to calibrate a medical device (e.g., anaesthesia unit, blood gas analyte, patient monitor) to verify that it measures, displays and/or supplies the proper gas type, concentration and/or quantity; it may in addition be used for testing a patient’s pulmonary function. The cylinder is filled with gas when delivered from the gas supplier.	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
Pressure: 2400 Pound per Square Inch
Total Volume: 8350 Liter

Device Record Status

Public Device Record Key: a0b7dfa2-eb50-45c1-9162-d877b26cb03c
Public Version Date: July 17, 2023
Public Version Number: 1
DI Record Publish Date: July 08, 2023