AccessGUDID - DEVICE: NeoPAP Cannula

GUDID

Device Identifier (DI) Information

Brand Name: NeoPAP Cannula - XL
Version or Model: 1078616
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1078616
Company Name: CIRCADIANCE, LLC

Primary DI Number: B0361078616
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012721295 *Terms of Use

Device Description: NeoPAP Cannula - XL

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a56d3d51-d814-44ab-a6bd-0f85bf1aecd4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: July 29, 2016