DEVICE: NeoPAP Cannula - S (B0361078612)

Device Identifier (DI) Information

NeoPAP Cannula - S
1078612
In Commercial Distribution
1078612
CIRCADIANCE, LLC
B0361078612
HIBCC

1
012721295 *Terms of Use
NeoPAP Cannula - S
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 Record Status

14855d25-7473-4d60-ae4e-95e8506de4d4
March 29, 2018
2
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
B0361074120 10 B0361078612 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
No
No CLOSE

Customer Contact

[?]
1-888-825-9640
info@circadiance.com
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