FDA.reportPublic FDA data

FOX MOBILE

Primary DI
05056143200024
Brand
FOX MOBILE
Company
VECTURA GROUP PLC
Model
FOX MOBILE Base Unit
Catalog number
08RS5000
Device description
The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K142059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142059000FOX MOBILEVectura GmbH2015-01-09CAF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056143202035PackageGS110In Commercial Distribution
05056143200024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056143202035050561432020355056143202035
05056143200024050561432000245056143200024

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, non-heatedAn assembly of devices designed to generate non-heated aerosolized medication/fluids (finely dispersed airborne droplets in a liquid-phase) intended to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It includes an electrically-powered generator, a reservoir, and a hand-held nebulizing chamber where the nebulization of the medicine usually takes place.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+498989796969fox.mobile@vectura.com
+498989796969regulatory@vectura.com

Regulatory Flags#

DUNS number
536137748
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05056143200000FOX MOBILENebuliser Mouthpiece08CD00022017-05-05
05056143200017FOX MOBILEFOX MOBILE Nebuliser Head08RS20002017-05-05
05056143200031FOX MOBILEFOX MOBILE Inhalation System (US)08CD00102017-05-05
05056143200055FOX MOBILEFOX MOBILE Inhalation Set (US)08CD00252017-05-05
05056143200093N/ANebuliser Handset01VB01002017-06-27
05056143200109N/AN/AN/A2017-06-27
05056143200116N/AN/AN/A2017-06-28
05056143200123N/ANebuliser Tube System01VB01032017-06-27
05056143200154AKITA JETAKITA JET Inhalation System01RS01002017-06-27
05056143200451N/ANebuliser Handset01VB01002017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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10197344006021HUDSON RCIMEDLINE INDUSTRIES, INC.CAF2023-12-15
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10840330700433ProcureTwin Med, LLCCAF2022-11-03
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10884389131657MedlineMEDLINE INDUSTRIES, INC.CAF2022-07-21
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