DEVICE: Fisher & Paykel Healthcare (09420012401106)
Device Identifier (DI) Information
Fisher & Paykel Healthcare
900MR559
In Commercial Distribution
900MR559
FISHER & PAYKEL HEALTHCARE LIMITED
900MR559
In Commercial Distribution
900MR559
FISHER & PAYKEL HEALTHCARE LIMITED
Hose heater adaptor
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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Yes | |
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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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60966 | Respiratory gas heating wire, adult |
A non-sterile device intended to be integrated within a ventilator breathing circuit and used in conjunction with a heated respiratory humidifier (from which it draws its power) to maintain the temperature of inspiratory gasses during ventilation of an adult patient. It typically consists of a compact heating unit and a length of heated wire which is integrated within the lumen of an adult breathing circuit tube. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K913368 | 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
4712d492-440d-4708-8624-ac73fd89824c
July 06, 2018
3
September 10, 2016
July 06, 2018
3
September 10, 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
[?]
1800 446 3908
Customer.CareUSA@fphcare.com
Customer.CareUSA@fphcare.com