DEVICE: Optitherm (04048551068663)
Device Identifier (DI) Information
Optitherm
20432030
In Commercial Distribution
Karl Storz GmbH & Co. KG
20432030
In Commercial Distribution
Karl Storz GmbH & Co. KG
Optitherm® Heating Element
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No | |
No | |
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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? |
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48168 | Insufflation gas conditioning system |
An assembly of devices used with a laparoscopic gas distention system or other gas source to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying the gas before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It typically consists of a mains electricity (AC-powered) control unit, a humidification chamber through which cold/dry gas passes for conditioning, and a tubing set for connection to the gas source and delivery of the conditioned gas to the operative site. Conditioning of the gas helps alleviate problems associated with gas insufflation, i.e., desiccation of internal tissue and body temperature loss.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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HIF | INSUFFLATOR, LAPAROSCOPIC |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
182d3b53-2d11-4733-a799-51f6f7b07da9
October 21, 2024
4
September 23, 2016
October 21, 2024
4
September 23, 2016
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
[?]
No Customer Contact currently defined