N/A N/A

GUDID 05056143200116

Set of 5 Bulk Pack in one shipment box

VECTURA GROUP PLC

Nebulizing system, non-heated
Primary Device ID05056143200116
NIH Device Record Key074ce356-8c40-4113-a6b5-eeefe0442731
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberN/A
Catalog NumberN/A
Company DUNS536137748
Company NameVECTURA GROUP PLC
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
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 TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
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
Handling Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105056143200116 [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 Date2017-06-28

On-Brand Devices [N/A]

05056143200451Nebuliser handset in printed polyethylene bag
05056143200123Nebuliser Tube System
05056143200116Set of 5 Bulk Pack in one shipment box
05056143200109Set of 10 nebuliser Sets and 10 Noseclips
05056143200093Nebuliser handset in printed polyethylene bag

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.