AccessGUDID - DEVICE: SleepWeaver Anew - Mask & Headgear - Regular

GUDID

Device Identifier (DI) Information

Brand Name: SleepWeaver Anew - Mask & Headgear - Regular - Blue
Version or Model: 100960
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 100960
Company Name: CIRCADIANCE, LLC

Primary DI Number: B036100960
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012721295 *Terms of Use

Device Description: SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Regular - Blue

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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
57814	CPAP/BPAP face mask, reusable	A flexible, form-shaped device designed to be placed over a user's nose and mouth 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 and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a reusable device.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130481	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: 41304ecd-7429-4003-908a-28783d73cd31
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016