FDA.reportPublic FDA data

Resp-O2 Compact Compressor Nebulizer

Primary DI
00840117308718
Brand
Resp-O2 Compact Compressor Nebulizer
Company
Dynarex Corporation
Model
34401
Device description
Adult/Pediatric
Published
2022-05-11
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
false

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
K091272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091272000BESMED JET NEBULIZER BOTTLE SETBesmed Health Business Corp2009-11-10CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117308725PackageGS16In Commercial Distribution
00840117308718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117308725008401173087258401173087250840117308725
00840117308718008401173087188401173087180840117308718

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
008124539
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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
00616784432120Cotton Tipped Plastic Applicators43212021-09-01
00616784432526Wooden Spoon, 3" (7.6 cm)43252026-04-27
00840117313347Resp-O2 Endotracheal Tube Introducer (Bougie), Pediatric, 10 FR362602022-05-17
00840117313385Resp-O2 Intubating Stylette, 6 Fr362652022-05-17
00840117313408Resp-O2 Intubating Stylette, 10 Fr362662022-05-17
00840117313422Resp-O2 Intubating Stylette, 12 Fr362672022-05-17
00840117315235Resp-O2 Intubating Stylette, 14 Fr362682022-05-17
00840117317451Resp-O2 Endotracheal Tube Cuffed, 4.0 mm362342024-10-24
00840117317468Resp-O2 Endotracheal Tube Cuffed, 4.5 mm362352024-10-24
00840117317482Resp-O2 Endotracheal Tube Cuffed, 5.5 mm362372024-10-24
00840117317499Resp-O2 Endotracheal Tube Cuffed, 6.0 mm362382024-10-24
00840117317505Resp-O2 Endotracheal Tube Cuffed, 6.5 mm362392024-10-24
00840117317512Resp-O2 Endotracheal Tube Cuffed, 7.0 mm362402024-10-24
00840117317529Resp-O2 Endotracheal Tube Cuffed, 7.5 mm362412024-10-24
00840117317536Resp-O2 Endotracheal Tube Cuffed, 8.0 mm362422024-10-24
00840117317543Resp-O2 Endotracheal Tube Cuffed, 8.5 mm362432024-10-24
00840117317550Resp-O2 Endotracheal Tube, Cuffed, 9.0 mm362442024-10-24
00840117318366Resp-O2 Durable Peak Flow Mouthpiece, With One-Way Valve, Adult361162021-04-22
00840117318373Resp-O2 Cardboard Peak Flow Mouthpiece, Disposable, Pediatric361172021-04-22
00840117318380Resp-O2 Cardboard Peak Flow Mouthpieces, Disposable, Adult361182021-04-22

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
10889483221747AirLife™SUNMED, LLCCAF2025-12-19
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
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
00840117308695Resp-O2 Elite Compressor Nebulizer, Adult/PediatricDynarex CorporationCAF2022-05-11
00840117308732My Resp-O2 Bear Compressor NebulizerDynarex CorporationCAF2022-05-11
10888277657625MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699205MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699229MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01
10888277699236MEDLINE INDUSTRIESMEDLINE INDUSTRIES, INC.CAF2021-10-01
00888277692100MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-05-18
00888277699215MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-05-18