FDA.reportPublic FDA data

MISTIC

Primary DI
612223300319
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
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
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 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
false
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
00607411919343Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-10
00607411919367Salter Labs® Full Kit Nebulizer SetSALTER LABSCAF2026-06-10
00607411919299MedTronic NebuTechSALTER LABSCAF2026-06-09
00607411919329Salter Labs® NebuTech®SALTER LABSCAF2026-06-09
00607411919350Salter Labs® Full Kit NebulizerSALTER LABSCAF2026-06-09
04719882305016MaxiNeb BANENCHANT TEK. CO, LTD.CAF2026-05-28
00848530107932Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2026-01-26
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
10197344012022HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-09-22
10197344011322HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-07-23
00789091681588Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-06-03
00848530096137Nebulizer KitSunset Healthcare Solutions, Inc.CAF2025-05-21
10197344006014HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2025-02-21
09420012463159Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDCAF2024-08-15
00848530087524Power and AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087531Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099893Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099923Nebulizer AccessoriesSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087517Nebulizer Medicine CupSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530099107Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-08-07
00848530087500Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093884Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095062Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530095079Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530089818Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530093853Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530094805Nebulizer KitSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530098216Aerosol & NebsSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100377Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30
00848530100384Nebulizer and CompressorSunset Healthcare Solutions, Inc.CAF2024-07-30