DEVICE: Penlon (05051977000116)

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Device Identifier (DI) Information

Penlon
Sigma Delta

PENLON LTD
05051977000116
GS1
1
The Sigma Delta vaporizer is designed for incorporation in the fresh gas supply system of continuous flow anaesthetic machines, directly connected between the flowmeter unit and the common gas outlet of the machine. Its purpose is the provision of accurate concentrations of the anaesthetic drugs into the fresh gas supply, according to the setting of the control dial.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
Sevoflurane anaesthesia vaporizer A device used to vaporize the anaesthetic agent sevoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.
Isoflurane anaesthesia vaporizer A device used to vaporize the anaesthetic agent isoflurane and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.
Halothane anaesthesia vaporizer A device used to vaporize the anaesthetic agent halothane (also known as fluorothane) and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.
Enflurane anaesthesia vaporizer A device used to vaporize the anaesthetic agent enflurane (Ethrane) and deliver a controlled amount of the agent to a patient being prepared for surgery. The device is usually mounted to an anaesthesia system or ventilator.
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FDA Product Code

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Product Code Product Code Name
CAD Vaporizer, Anesthesia, Non-Heated
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Sterilization

No
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Sterilization Method [?]
No Sterilization Methods Found
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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
July 26, 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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None
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Production Identifier(s) in UDI

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Customer Contact

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800-328-6216
customer.service@penlon.com
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