DEVICE: TC 560 Contact Liquid (07332834000264)

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Device Identifier (DI) Information
TC 560 Contact Liquid
TC 560
In Commercial Distribution

Perimed AB
07332834000264
GS1

1
354765570 *Terms of Use
TC 560 Contact Liquid (20 ml)
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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GMDN

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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?
46934 Transcutaneous blood gas monitoring system
An assembly of mains electricity (AC-powered) devices designed for the continuous and transcutaneous measurement of a patient's blood gas parameters, typically blood partial pressure of oxygen (pO2), blood partial pressure of carbon dioxide (pCO2), haemoglobin oxygen saturation (SpO2), and/or venous blood oxygenation through the jugular vein (SjvO2); often with pulse rate. It consists primarily of a probe for gas detection (e.g., via transcutaneous gas diffusion, or using light spectroscopy) placed on the patient’s skin, and an oximetry monitor for the measurement, analysis, and display of data; patient adhesives and connecting cables may be included.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LKD Monitor, Carbon-Dioxide, Cutaneous
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K990960 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 5 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
796227bc-964e-458f-bd3a-809877d1b3f6
May 08, 2023
5
September 13, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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