DEVICE: NeoPAP Bonnet - S (B0361078536)

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Device Identifier (DI) Information

NeoPAP Bonnet - S
1078536
1078536
CIRCADIANCE, LLC
B0361078536
HIBCC
1
NeoPAP Bonnet - S
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
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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
Neonatal CPAP unit A mains electricity (AC-powered) device, which may include rechargeable batteries, intended to assist noninvasive ventilation (i.e., without use of an artificial airway) of a neonatal/infant patient via an attached nasal cannula or mask, using continuous positive airway pressure (CPAP) during spontaneous respiration. It is an electronic unit with controls, and may be used with compressed medical gas cylinders [e.g., air, oxygen (O2)] or include an O2 concentrator compartment; additional features (e.g., adjustable flow rates and O2 concentration, humidification) may be provided. It is primarily intended for use in a healthcare facility, especially in intensive and critical care settings.
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FDA Product Code

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Product Code Product Code Name
BZD Ventilator, Non-Continuous (Respirator)
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Sterilization

No
No
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 29, 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
B0361074084 10 B0361078536 In Commercial Distribution Single
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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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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
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No CLOSE

Customer Contact

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1-888-825-9640
info@circadiance.com
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