DEVICE: Scott Medical Products (00819601022560)
Device Identifier (DI) Information
Scott Medical Products
Calibration Gas
In Commercial Distribution
Z02NI794WDC000
AIRGAS USA LLC
Calibration Gas
In Commercial Distribution
Z02NI794WDC000
AIRGAS USA LLC
Description: 21% O2, BAL. N2;
Cylinder: WD;
Valve: CGA C-10;
For calibration of medical analyzers in accordance with manufacturer's instructions.;
CE Marked
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
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 |
Clinically Relevant Size
[?]Size Type Text |
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Pressure: 1000 Pound per Square Inch |
Total Volume: 105 Liter |
Device Record Status
24a4e0d5-5e91-4587-ba45-c83044ede387
May 17, 2021
2
February 22, 2021
May 17, 2021
2
February 22, 2021
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