AccessGUDID - DEVICE: CURAPLEX (00612223300296)

GUDID

Device Identifier (DI) Information

Brand Name: CURAPLEX
Version or Model: P3000BHC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 301-P3000BH
Company Name: PEGASUS RESEARCH CORPORATION

Primary DI Number: 00612223300296
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 185432994 *Terms of Use

Device Description: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, PACKAGED WITH 500ML BOTTLE

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:	Yes
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?
61167	Nebulizing adaptor	A non-powered small connecting device, which includes an integrated nebulizer, intended to join a sterile water or sterile isotonic sodium chloride solution reservoir to a respiratory gas source (typically wall outlet) and a gas administration device (e.g., mask, mouthpiece). It is designed to generate aerosolized fluid (finely dispersed airborne droplets in a liquid phase) to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. 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 [?]
K962534	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
Height: 3.5 Inch
Outer Diameter: 2.5 Inch
Length: 12 Inch

Device Record Status

Public Device Record Key: 124f24b9-a483-4990-8ffc-256de69a76e5
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016