FDA.reportPublic FDA data

Protekt Nebulizer

Primary DI
05060488573620
Brand
Protekt Nebulizer
Company
PROACTIVE MEDICAL PRODUCTS, LLC
Model
PMNEBRDK-PP
Catalog number
PMNEBRDK-PP
Device description
Protekt Pediatric Nebulizer w/ Disposable and Reusable Neb Kit, w/ Pediatric Mask - Pink Pig
Published
2022-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K123030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123030000COMPRESSOR NEBULIZER MODEL MCN-S600XXDongguan Aidisy Machinery & Electronic Equipment C2013-12-19CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488573637PackageGS110In Commercial Distribution
05060488573620PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488573637050604885736375060488573637
05060488573620050604885736205060488573620

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent vaporizer, benchtopAn assembly of devices intended to be used in the home and clinical settings to vaporize (through heating) medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It includes an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held inhalation compartment (e.g., inflatable balloon with mouthpiece).¿¿It is designed to be placed on a benchtop/flat surface during use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height8Inch
Length6Inch
Width9Inch

Contacts#

Phone, Email table
PhoneEmail
+1 (855) 237 7622sales@proactivemedical.com

Regulatory Flags#

DUNS number
078582655
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05061105057455Protekt VX 5000PMVSM5000PMVSM50002025-12-18
05060488573293Protekt PartsPP-AHDAASMK3LFTPP-AHDAASMK3LFT2022-11-18
05060488573309Protekt PartsPP-AHDAASMK3RTPP-AHDAASMK3RT2022-11-18
05060488573316Protekt PartsPP-AHFAASMK3LFTPP-AHFAASMK3LFT2022-11-18
05060488573323Protekt PartsPP-AHFAASMK3RTPP-AHFAASMK3RT2022-11-18
05060488572401Protekt LiftPL400HPL400H2022-05-11
05060488570902Procure Nebulizer002-102785002-1027852020-01-01
05060488570926Procure Blood Pressure Monitor, Digital, Auto Inflate w/ Batteries002-102738002-1027382020-01-01
05060488570162Protekt Aire94001940012016-08-12
05060488570179Protekt Aire94003940032016-08-12
05060488570186Protekt Aire94004940042016-08-12
05060488570452Protekt Aire Replacement Pump80091800912016-08-12
05060488570490Protekt Aire Replacement Mattress80032800322016-08-12
05060488570506Protekt Aire Replacement Mattress80042800422016-08-12
05060488570544Protekt Aire Replacement Mattress80082800822016-08-12
05060488570551Protekt Aire Replacement Mattress80087800872016-08-12
05060488570728Protekt Aire83500835002018-03-07
05060488570735Protekt Aire83600836002018-03-07
05060488570742Protekt Aire84600846002018-03-07
05060488570773Protekt Aire81090-42B81090-42B2018-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
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10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
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10190752148369AirLife™AIRLIFECAF2021-04-09
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