FDA.reportPublic FDA data

Portex

Primary DI
50788942141009
Brand
Portex
Company
SMITHS MEDICAL ASD, INC.
Model
11-4100
Published
2016-10-11
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
true

Product Codes#

Code, Name table
CodeName
CAFNEBULIZER (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAFNebulizer (Direct Patient Interface)Anesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50788942141009PackageGS125In Commercial Distribution
10788942141001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5078894214100950788942141009
1078894214100110788942141001

GMDN Terms#

Term, Definition table
TermDefinition
Benchtop nebulizer, non-heatedAn assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
828611934
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
50351688508896MedexMX207752016-10-11
50351688508933MedexMX207552016-10-11
50610674800094PortexH4003PS2015-09-01
30610674802094PortexH4021PS2015-09-01
30610674802780PortexH4022PS2015-09-01
50351688500302MedexTF562016-10-13
50351688500319MedexTF552016-12-29
50351688500487MedexSM7223SC2016-10-13
50351688500555MedexSM50142017-01-03
50351688500647MedexSM50042017-01-03
50351688500654MedexSM50032017-01-03
50351688504638MedexMX8702016-10-13
50351688505031MedexMX8012016-10-13
50351688505406MedexMX7452017-02-27
50351688505413MedexMX7432016-10-13
50351688506878MedexMX4982016-10-12
50351688506922MedexMX4922016-10-12
50351688507097MedexMX457L2016-10-12
50351688507103MedexMX4572016-10-12
50351688507189MedexMX453L2016-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
10193489016376MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10884389131640MedlineMEDLINE INDUSTRIES, INC.CAF2022-06-10
10190752141780AirLife™AIRLIFECAF2021-05-07
10190752160613AirLife™VYAIRE MEDICAL, INC.CAF2021-05-07
10190752160620AirLife™AIRLIFECAF2021-05-07
10190752148369AirLife™AIRLIFECAF2021-04-09
10190752114883AirLife™VYAIRE MEDICAL, INC.CAF2021-04-02
10190752141766AirLife™AIRLIFECAF2021-04-02