FDA.reportPublic FDA data

Dynarex My Resp-O2 Doggy Compressor Nebulizer

Primary DI
00840117308756
Brand
Dynarex My Resp-O2 Doggy Compressor Nebulizer
Company
Dynarex Corporation
Model
34403
Published
2021-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K043238000
K091272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043238000COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIESEmg Technology Co., Ltd.2005-07-06CAF
K091272000BESMED JET NEBULIZER BOTTLE SETBesmed Health Business Corp2009-11-10CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117308763PackageGS14In Commercial Distribution
00840117308756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117308763008401173087638401173087630840117308763
00840117308756008401173087568401173087560840117308756

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117309210Resp-O2 Suction Tubing Combo Pack, Non-Sterile321002021-04-22
00840117309234Resp-O2 Suction Connecting Tubing, Non-Conductive321032021-04-22
00840117309258Resp-O2 Suction Connecting Tubing, Non-Conductive321042021-04-22
00840117309272Resp-O2 Suction Connecting Tubing, Non-Conductive321062021-04-22
00840117309296Resp-O2 Suction Connecting Tubing, Non-Conductive321072021-04-22
00840117309371Resp-O2 Suction Connecting Tubing, Non-Conductive321112021-04-22
00840117309395Resp-O2 Suction Connecting Tubing, Non-Conductive321122021-04-22
00840117313651Resp-O2 Suction Connecting Tubing, Non-Conductive321052021-04-22
00840117309418Resp-O2 Yankauer Suction Handle, Bulb Tip, Vented,321202022-05-10
00840117309432Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321212022-05-10
00840117309456Resp-O2 Yankauer Suction Handle, Straight Tip, Vented321222022-05-10
00840117309319Resp-O2 Suction Connecting Tubing, Non-Conductive321082022-05-09
00840117309326Resp-O2 Suction Connecting Tubing, Non-Conductive321092022-05-09
00840117309357Resp-O2 Suction Connecting Tubing, Non-Conductive321102022-05-09
00840117309494Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321262022-05-09
00840117309470Resp-O2 Yankauer Suction Handle, Straight Tip, Non-Vented321232022-04-21
00840117313675Resp-O2 Yankauer Suction Handles, Bulb Tip, Non-Vented321252022-04-21
00840117313699Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321272022-04-21
00840117313712Resp-O2 Yankauer Suction Handle, Bulb Tip, Non-Vented321282022-04-21
00840117321748Resp-O2 Suction Connecting Tubing, Non-Sterile321012022-04-21

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
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10840330700457ProcureTwin Med, LLCCAF2022-11-03
10840330700464ProcureTwin Med, LLCCAF2022-11-03
10840330700471ProcureTwin Med, LLCCAF2022-11-03
10840330700488ProcureTwin Med, LLCCAF2022-11-03
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10888277657625MEDLINEMEDLINE INDUSTRIES, INC.CAF2021-10-01