FDA.reportPublic FDA data

MISTIC

Primary DI
00612223300364
Brand
MISTIC
Company
PEGASUS RESEARCH CORPORATION
Model
P3000HAL
Catalog number
P3000HAL
Device description
ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, AIRLIFE FIT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K962534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962534000THERA-MIST NEBULIZER MODEL-P3000Pegasus Research Corp.1997-02-28CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
612223300319PackageGS140In Commercial Distribution
00612223300364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
612223300319006122233003196122233003190612223300319
00612223300364006122233003646122233003640612223300364

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing adaptorA 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.

Device Sizes#

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

Regulatory Flags#

DUNS number
185432994
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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