DEVICE: Scott Medical Products (00819601020559)

Device Identifier (DI) Information

Scott Medical Products
Calibration Gas
In Commercial Distribution
Z03NI748BDC002
AIRGAS USA LLC
00819601020559
GS1

1
831996595 *Terms of Use
Description: 5% CO2, 21% O2, Bal. N2 with Filter Line (2-Pack); Cylinder: BD; Valve: Aerosol; For calibration of medical analyzers in accordance with manufacturer's instructions.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BXK Gas, Calibration (Specified Concentration)
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FDA Premarket Submission

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

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: less than 52 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
Total Volume: 10 Liter
Pressure: 144 Pound per Square Inch
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Device Record Status

1c52dddf-e4f1-4294-9ce6-b11c4da16910
May 17, 2021
2
September 14, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
18002334334
customerservice.healthcare@airliquide.com
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