AccessGUDID - DEVICE: SleepWeaver Advance - Mask & Headgear

GUDID

Device Identifier (DI) Information

Brand Name: SleepWeaver Advance - Mask & Headgear - Camo
Version or Model: 100281
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100281
Company Name: CIRCADIANCE, LLC

Primary DI Number: B036100281
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012721295 *Terms of Use

Device Description: SleepWeaver Advance Cloth Nasal CPAP Mask & Headgear - Camo

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:	No
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

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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
CPAP/BPAP nasal mask, reusable	A 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 reusable device.

GMDN Preferred Term Name

GMDN Definition

CPAP/BPAP nasal mask, reusable

A 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 reusable device.

FDA Product Code

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092362	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

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 45f82d9d-ee12-491a-a740-9e5067f12e04
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 22, 2016