DEVICE: Calibration Gas (05700699621887)

Device Identifier (DI) Information

Calibration Gas
962-188
In Commercial Distribution
962-188
Radiometer Medical ApS
05700699621887
GS1

1
308667539 *Terms of Use
TCM4 CAL GAS
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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
LKD MONITOR, CARBON-DIOXIDE, CUTANEOUS
LPP Monitor, oxygen, cutaneous, for uses other than for infant not under gas anesthesia
DPZ Oximeter, ear
KLK Monitor, oxygen, cutaneous, for infant not under gas anesthesia
DQA Oximeter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn, even after use.
Storage Environment Temperature: between 4 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

670c3ab9-1ce8-4e1d-962d-a574434ad9bf
September 05, 2023
3
September 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
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