FDA.reportPublic FDA data

Resp-O2 Small Volume Nebulizer 6 cc Cup

Primary DI
00840117308657
Brand
Resp-O2 Small Volume Nebulizer 6 cc Cup
Company
Dynarex Corporation
Model
34120
Device description
7' (2.1 m) Tubing, Standard Connector, With Adult Aerosol Elongated Mask
Published
2021-04-22
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
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
K091272000
K150591000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091272000BESMED JET NEBULIZER BOTTLE SETBesmed Health Business Corp2009-11-10CAF
K150591000Besmed Reusable Jet NebulizerBesmed Health Business Corp2015-06-30CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117308664PackageGS150In Commercial Distribution
00840117308657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117308664008401173086648401173086640840117308664
00840117308657008401173086578401173086570840117308657

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system delivery set, reusableA collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.

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
false
Manufacturing date on label
false
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
00840117308558Resp-O2 Aerosol Standard Adult Mask340002021-04-22
00840117308572Resp-O2 Aerosol Elongated Masks, Adult340032021-04-22
00840117308619Resp-O2 Small Volume Nebulizer 6 cc Cup341042021-04-22
00840117308633Resp-O2 Small Volume Nebulizer 6cc Cup341052021-04-22
00840117311732Resp-O2 Aerosol Standard Mask, Pediatric340012021-04-22
00840117311770Resp-O2 Aerosol Elongated Masks, Pediatric340042021-04-22
00840117311794Resp-O2 Aerosol Face Tent Mask, Adult340052021-04-22
00840117311817Resp-O2 Small Volume Nebulizer341002021-04-22
00840117311831Resp-O2 Small Volume Nebulizer 6 cc Cup341012021-04-22
00840117311855Resp-O2 Small Volume Nebulizer 6 cc Cup341022021-04-22
00840117311879Resp-O2 Small Volume Nebulizer 6 cc Cup341032021-04-22
00840117311893Resp-O2 Small Volume Nebulizer 6 cc Cup341062021-04-22
00840117311916Resp-O2 Small Volume Pacifier Nebulizer Kit341072021-04-22
00840117318007Resp-O2 Tracheostomy Adult Mask340212021-04-22
00840117318014Resp-O2 Tracheostomy Pediatric Mask340222021-04-22
00840117318069Resp-O2 Tracheostomy Adult Mask340202021-04-22
00840117311756Resp-O2 Aerosol Standard Mask, Infant340022021-01-19
00840117311534Resp-O2 Oxygen Supply Tubing332002021-04-22
00840117311558Resp-O2 Oxygen Supply Tubing332012021-04-22
00840117311572Resp-O2 Oxygen Supply Tubing332022021-04-22

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
10840330700426ProcureTwin Med, LLCCAF2022-11-03
10840330700433ProcureTwin Med, LLCCAF2022-11-03
10840330700440ProcureTwin Med, LLCCAF2022-11-03
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
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