AirGent-2.0

GUDID 07290017151007

The AirGent-2.0 system is a pneumatically powered system that features a safe, minimally-invasive platform for uniformed administration of therapeutic

PERFACTION TECHNOLOGIES LTD

Needleless medication/vaccine injector, pneumatic

• Primary Device ID: 07290017151007
• NIH Device Record Key: fdfef7cb-4e5a-4a0b-97ce-9831128ad43e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AirGent-2.0
• Version Model Number: AA
• Company DUNS: 514595888
• Company Name: PERFACTION TECHNOLOGIES LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290017151007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082138

FDA Product Code

• KZE: Injector, Fluid, Non-Electrically Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-18
• Device Publish Date: 2018-12-18