DEVICE: Fisher & Paykel Healthcare (09420012461186)

Device Identifier (DI) Information

Fisher & Paykel Healthcare
950N61J
In Commercial Distribution
950N61J
FISHER & PAYKEL HEALTHCARE LIMITED
09420012461186
GS1

1
590153276 *Terms of Use
Nasal CPAP Flow Driver Circuit Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
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?
37706 Ventilator breathing circuit, single-use
An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator to a patient artificial airway/respiratory mask (not included). It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit; some types may include a carbon dioxide cuvette and/or an integrated heating wire powered by a connected humidifier intended to warm breathing gases as they enter the patient's airway. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K220703 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 50 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ef67d7af-1434-4a5b-bca9-4dde94c5d067
November 13, 2023
1
November 05, 2023
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
09420012461292 10 09420012461186 In Commercial Distribution BOX
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
1800 446 3908
Customer.CareUSA@fphcare.com
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