AccessGUDID - DEVICE: Jaeger Medical (00819601025646)

GUDID

Device Identifier (DI) Information

Brand Name: Jaeger Medical
Version or Model: Pulmonary Function Calibration Gas
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z04NI785EDC010
Company Name: Airgas Therapeutics, LLC

Primary DI Number: 00819601025646
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118537769 *Terms of Use

Device Description: Description: 0.3% CO, 0.3% CH4, 21% O2, BAL. N2; Cylinder: ED; Valve: CGA 500; For use with Jaeger Medical's Pulmonary Function Diagnostic Equipment in accordance with manufacturer's instructions.; Jaeger Medical Part #: 768093

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?
65331	Calibration gas/non-refillable cylinder	A gas or custom mix of gases (e.g., CO2, O2, N2) in a dedicated, 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. This device is reusable until the contents of the container are exhausted.	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: 1833 Pound per Square Inch
Total Volume: 475 Liter

Device Record Status

Public Device Record Key: 64293edf-1268-4122-ac5a-9c8a63d40658
Public Version Date: May 09, 2025
Public Version Number: 1
DI Record Publish Date: May 01, 2025