DEVICE: Fisher and Paykel Healthcare (09420012432681)
Device Identifier (DI) Information
Fisher and Paykel Healthcare
BC801-10
In Commercial Distribution
BC801-10
FISHER & PAYKEL HEALTHCARE LIMITED
BC801-10
In Commercial Distribution
BC801-10
FISHER & PAYKEL HEALTHCARE LIMITED
Infant Nasal Mask Medium BCPAP
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
37591 | CPAP/BPAP nasal mask, single-use |
A non-sterile, flexible, form-shaped device designed to be placed over a user's nose to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic and/or silicone materials that create an airtight seal around the nose. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BYG | Mask, Oxygen |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -10 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Medium |
Device Record Status
85b152ac-6f90-4abd-b665-5aaabb19ccd1
August 10, 2022
1
August 02, 2022
August 10, 2022
1
August 02, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
09420012423436 | 10 | 09420012432681 | In Commercial Distribution | PACK |
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