AKITA JET

GUDID 05056143200154

The Akita Jet Device is a breath actuated jet nebuliser with active flow and volume control to ensure precise drug dosing and targeting. It is intended only on conscious, cooperative adults and children with severe asthma. It is designed for temporary oral inhalation of the aerosol created by the device. The system is intended for single patient use.

VECTURA GROUP PLC

Nebulizing system, non-heated
Primary Device ID05056143200154
NIH Device Record Key700746d9-f0ba-4aee-8625-5aa8e08aae7b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAKITA JET
Version Model NumberAKITA JET Inhalation System
Company DUNS536137748
Company NameVECTURA GROUP PLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com
Phone+498989796969
Emailinfo@akita-jet.com

Operating and Storage Conditions

Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS105056143200154 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAFNebulizer (Direct Patient Interface)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-05-29
Device Publish Date2017-06-27

Devices Manufactured by VECTURA GROUP PLC

05056143200055 - FOX MOBILE2019-09-17 The FOX MOBILE Inhalation Set (US) is part of the FOX MOBILE Inhalation System (US) and consists of following components: Nebuli
05056143200000 - FOX MOBILE2019-05-29 The Nebuliser Mouthpiece is part of the FOX MOBILE Inhalation Set.
05056143200017 - FOX MOBILE2019-05-29 The FOX MOBILE Nebulizer Head is part of the FOX MOBILE Inhalation Set.
05056143200024 - FOX MOBILE2019-05-29 The FOX MOBILE Base Unit is part of the FOX MOBILE Inhalation System.
05056143200031 - FOX MOBILE2019-05-29 The FOX MOBILE Inhalation System consists of following components: base unit, charger, Inhalation set, carry case, instructions
05056143200093 - N/A2019-05-29 Nebuliser handset in printed polyethylene bag
05056143200109 - N/A2019-05-29 Set of 10 nebuliser Sets and 10 Noseclips
05056143200116 - N/A2019-05-29 Set of 5 Bulk Pack in one shipment box

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