DEVICE: Scott Medical Products (00819601024748)
Device Identifier (DI) Information
Scott Medical Products
Anesthesia Calibration Gas
In Commercial Distribution
Z02AI91MUD0001
AIRGAS USA LLC
Anesthesia Calibration Gas
In Commercial Distribution
Z02AI91MUD0001
AIRGAS USA LLC
Description: 9% DESFLURANE, BAL. AIR;
Cylinder: UD;
Valve: CGA 165;
For calibration of medical analyzers in accordance with manufacturer's instructions.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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.
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FDA Product Code
[?]Product Code | Product Code Name |
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BXK | Gas, Calibration (Specified Concentration) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: less than 52 Degrees Celsius |
Handling Environment Temperature: more than 0 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Pressure: 29 Pound per Square Inch |
Total Volume: 44 Liter |
Device Record Status
896cd697-be14-420f-8b65-f50c2bced74d
February 20, 2023
1
February 12, 2023
February 20, 2023
1
February 12, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-233-4334
customerservice.healthcare@airliquide.com
customerservice.healthcare@airliquide.com