FDA.reportPublic FDA data

MISTIC

Primary DI
00612223035013
Brand
MISTIC
Company
PEGASUS RESEARCH CORPORATION
Model
P3500
Catalog number
P3500
Device description
HUMIDIFIER
Published
2016-09-27
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
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K894000000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K894000000THERA-MIST HUMIDIFIERPegasus Research Corp.1989-08-28BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
612223035006PackageGS120In Commercial Distribution
00612223035013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
612223035006006122230350066122230350060612223035006
00612223035013006122230350136122230350130612223035013

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height4.5Inch
Length12Inch
Outer Diameter4.125Inch

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

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Primary DI, Brand, Company table
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