DEVICE: NeoPAP Cannula - S (B0361078612)
Device Identifier (DI) Information
NeoPAP Cannula - S
1078612
In Commercial Distribution
1078612
CIRCADIANCE, LLC
1078612
In Commercial Distribution
1078612
CIRCADIANCE, LLC
NeoPAP Cannula - S
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
---|---|---|---|---|
61197 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BZD | Ventilator, Non-Continuous (Respirator) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K103410 | 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
14855d25-7473-4d60-ae4e-95e8506de4d4
July 06, 2018
3
July 29, 2016
July 06, 2018
3
July 29, 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 |
---|---|---|---|---|---|
B0361074120 | 10 | B0361078612 | In Commercial Distribution | Single |
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
[?]
1-888-825-9640
info@circadiance.com
info@circadiance.com