FDA.reportPublic FDA data

CURAPLEX

Primary DI
00612223030100
Brand
CURAPLEX
Company
PEGASUS RESEARCH CORPORATION
Model
301-P3000NCF
Catalog number
P3000NCC
Device description
ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT
Published
2021-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CAFNebulizer (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K893942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K893942000THERA-MIST(TM) NEBULIZER, MODEL 30000Pegasus Research Corp.1989-08-28CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612223030100PackageGS140In Commercial Distribution
00612223030117PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612223030100006122230301006122230301000612223030100
00612223030117006122230301176122230301170612223030117

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing adaptorA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height3.5Inch
Length14.5Inch
Outer Diameter2.5Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
185432994
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612223200121CURAPLEX301-P2001CFP2001CC2021-09-15
00612223057053THERMAGARD5705P20001H2016-09-23
00612223200015PEGASUSP2001P20012016-09-23
00612223200114CURAPLEX301-P2001P2001C2016-09-23
00612223060015PEGASUSP6000P60002021-09-17
00612223060510PEGASUSP6050P60502021-09-17
00612223061012PEGASUSP6100P61002021-09-17
00612223062019PEGASUSP6200P62002021-09-17
00612223062514PEGASUSP6250P62502021-09-17
00612223063016PEGASUSP6300P63002021-09-17
00612223030117CURAPLEX301-P3000NCFP3000NCC2021-09-15
00612223030131CURAPLEX301-P3000NCF-LP3000NCC-L2021-09-15
00612223030155CURAPLEX301-P3000NCF-SP3000NCC-S2021-09-15
00612223030223MISTICP3000H-CANP3000H-CAN2016-09-23
00612223030247CURAPLEX301-P3000HCFP3000HCC2021-09-15
00612223030261CURAPLEX301-P3000HCF-LP3000HCC-L2021-09-15
00612223030285CURAPLEX301-P3000HCF-SP3000HCC-S2021-09-15
00612223030339CURAPLEX301-P3000HBP3000HB2021-09-15
00612223030353CURAPLEX301-P3000CDP3000CD2021-09-15
00612223300050MISTICP3000NP3000N2016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
10304040194390Henry ScheinHENRY SCHEIN, INC.CAF2025-12-15
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344012541HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
10197344137251HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-05-07
10197344137244HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-04-11
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
10197344077564HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-03-05
10193489138436HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138443HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138467HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10193489138481HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2024-02-13
10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02