BETACONNECT 82289801

GUDID 05713495000015

Phillips-Medisize A/S

Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded injector, manual, professional Syringe-loaded medication/vaccine injector, manual, professional Syringe-loaded medication/vaccine injector, manual, professional Syringe-loaded medication/vaccine injector, manual, professional Syringe-loaded medication/vaccine injector, manual, professional Syringe-loaded medication/vaccine injector, manual, professional Syringe-loaded medication/vaccine injector, manual, professional

• Primary Device ID: 05713495000015
• NIH Device Record Key: 761886b5-14c7-41bb-8958-1547f5e06510
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BETACONNECT
• Version Model Number: 82289801
• Catalog Number: 82289801
• Company DUNS: 306047440
• Company Name: Phillips-Medisize A/S
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	05713495000015 [Primary]
GS1	05713495000022 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• KZH: Introducer, Syringe Needle

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-10-15
• Device Publish Date: 2019-10-07

Devices Manufactured by Phillips-Medisize A/S

• 05713495000084 - Skytrofa Auto-Injector: 2021-11-01
• 05713495000015 - BETACONNECT: 2021-10-15
• 05713495000015 - BETACONNECT: 2021-10-15
• 05713495000039 - myBETAapp: 2021-10-15
• 05713495000046 - myBETAapp: 2021-10-15
• 05713495000053 - myBETAapp: 2021-10-15
• 05713495000060 - myBETAapp: 2021-10-15