DEVICE: Penlon (05051977000116)
Device Identifier (DI) Information
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? |
---|---|---|---|---|
36980 | 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.
|
Active | false |
36890 | 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.
|
Active | false |
36891 | 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.
|
Active | false |
36316 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
CAD | Vaporizer, Anesthesia, Non-Heated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K002343 | 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
f315934c-ba7d-4668-95df-54d9720d640a
June 22, 2023
4
July 26, 2016
June 22, 2023
4
July 26, 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
[?]
800-328-6216
customer.service@penlon.com
customer.service@penlon.com