AccessGUDID - DEVICE: Circulaire II Hybrid Aerosol Drug Delivery System (00709078000812)

GUDID

Device Identifier (DI) Information

Brand Name: Circulaire II Hybrid Aerosol Drug Delivery System
Version or Model: 0393R
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WESTMED, INC.

Primary DI Number: 00709078000812
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 092673953 *Terms of Use

Device Description: with reusable VixOne, Mouthpiece

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):	No
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?
31309	Nebulizing system delivery set, single-use	A collection of flexible tubing, typically non-sterile, and associated items that may include a mask or mouthpiece, a medication chamber, and connectors, used with a nebulizer to deliver an aerosol, usually medicated, to the patient's respiratory system. It is made of synthetic material and is typically a thick-walled, anti-kink tubing to prevent blockage. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAF	Nebulizer (Direct Patient Interface)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K926055	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: 77e904b8-ad86-43fb-bf9d-f1776c1065dc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 16, 2016