DEVICE: Optitherm (04048551068663)

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Device Identifier (DI) Information

Optitherm
20432030

Karl Storz GmbH & Co. KG
04048551068663
GS1
1
Optitherm® Heating Element
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
HIF INSUFFLATOR, LAPAROSCOPIC
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 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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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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