CURAPLEX - CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT - PEGASUS RESEARCH CORPORATION

Duns Number:185432994

Device Description: CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT TUBE, UP TO 40 LPM, AIRLIFE FIT

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More Product Details

Catalog Number

P3000HCC-S

Brand Name

CURAPLEX

Version/Model Number

301-P3000HCF-S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K962534,K962534

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

dcac2c89-4536-459b-ba07-7407db000af1

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

September 15, 2021

Additional Identifiers

Package DI Number

00612223030278

Quantity per Package

40

Contains DI Package

00612223030285

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"PEGASUS RESEARCH CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 47