DEVICE: PF 6840-1 TC Remote Panel 1 Channel (07332834000790)
Device Identifier (DI) Information
PF 6840-1 TC Remote Panel 1 Channel
PF 6840-1
In Commercial Distribution
Perimed AB
PF 6840-1
In Commercial Distribution
Perimed AB
PF 6840-1 TC Remote Panel 1 Channel
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? |
|---|---|---|---|---|
| 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.
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Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LPP | Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K131253 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
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| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
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| No Device Sizes |
Device Record Status
ee1cf39f-e404-4b23-b1d7-71dccf35d325
February 09, 2023
1
February 01, 2023
February 09, 2023
1
February 01, 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 |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
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| No Secondary DIs found | |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined