FDA.reportPublic FDA data

Pulmo-Mist Compressor

Primary DI
00038214001797
Brand
Pulmo-Mist Compressor
Company
NIDEK MEDICAL PRODUCTS, INC.
Model
4335
Published
2026-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020797000PULMO-MIST COMPRESSOR MODEL # 4323Nidek Medical Products, Inc.2002-05-03BTI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00038214001797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00038214001797000382140017970382140017970038214001797

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic agent nebulizer, benchtopAn assembly of devices intended to be used in the home and clinical to aerosolize medication/fluids, by non-heat-dependent means (i.e., not a vaporizer), for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation. It is designed to be placed on a benchtop/flat surface during use.

Regulatory Flags#

DUNS number
161382940
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
00038214001773Pulmo-Mist Compressor43232026-04-20
00038214001780Pulmo-Mist Compressor 43342026-04-20
00038214002732Penta Flow Oxygen Flow Splitter2952023-12-13
00038214002466NUVO NANO8558552023-06-07
00038214000028MARK 5 NUVO LITE9209202016-08-22
00038214000035MARK 5 NUVO LITE9259252016-08-23
00038214000066MARK 5 NUVO LITE925-IS925-IS2016-08-23
00038214000073MARK 5 NUVO LITE3935UK935UK2016-08-15
00038214000080MARK 5 NUVO LITE39359352016-08-15
00038214000097MARK 5 NUVO LITE920NI920NI2016-08-22
00038214000226MARK 5 NUVO 89809802016-08-23
00038214000233MARK 5 NUVO 89859852016-08-24
00038214000370MARK 5 NUVO LITE920/60920/602016-08-22
00038214000431MARK 5 NUVO LITE925/60925/602016-08-23
00038214000769MARK 5 NUVO LITE5205202016-08-15
00038214000806MARK 5 NUVO LITE5255252016-08-22
00038214000851MARK 5 NUVO 85805802016-08-23
00038214000868MARK 5 NUVO 85855852016-08-23
00038214000882MARK 5 NUVO LITE925NEB925NEB2016-08-23
00038214000905MARK 5 NUVO LITE520M520M2016-08-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050863438MedPakLIFEPORT, LLCBTI2026-05-06
00038214001773Pulmo-Mist CompressorNIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00038214001780Pulmo-Mist Compressor NIDEK MEDICAL PRODUCTS, INC.BTI2026-04-20
00762860000582OMBRA* Table Top Compressor System Trudell Medical InternationalBTI2025-11-06
10197344149070MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149087MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149094MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344149100MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-11-03
10197344135592MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-14
10197344135585MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154180MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154197MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344154203MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-08-06
10197344135578MEDLINEMEDLINE INDUSTRIES, INC.BTI2025-07-28
00197344042817MedlineMEDLINE INDUSTRIES, INC.BTI2024-02-16
00810050862745Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2024-01-11
00810050862707Utility Pedestal AssemblyLIFEPORT, LLCBTI2023-12-15
00810050862691Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-12-08
00810050862677Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-11-10
00810050862615Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862622Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-10-23
00810050862523Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862530Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862547Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-08-23
00810050862431Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-06-06
00810050862363Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862370Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-03-16
00810050862325Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07
00810050862332Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-02-07
00810050862295Patient Loading Utility System (PLUS)LIFEPORT, LLCBTI2023-01-27