APOTECAsyringe

GUDID 05060304050250

Automatic system for filling syringes

AEA SRL

Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system Pharmaceutical fluid-dispensing system

• Primary Device ID: 05060304050250
• NIH Device Record Key: a8cccd37-4483-45a7-aa7d-74ccc13cf3a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOTECAsyringe
• Version Model Number: APOTECAsyringe
• Company DUNS: 429415227
• Company Name: AEA SRL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060304050250 [Primary]

FDA Product Code

• NEP: System/Device, Pharmacy Compounding

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: 2021-03-09
• Device Publish Date: 2021-03-01

Devices Manufactured by AEA SRL

• 05060304050960 - APOTECA: 2022-03-24 Pharmacy compounding dosing device
• 05060304050977 - APOTECA: 2022-03-24 Pharmacy compounding dosing device
• 05060304050984 - APOTECA: 2022-03-24 Pharmacy compounding dosing device
• 05060304050991 - APOTECA: 2022-03-24 Pharmacy compounding dosing device
• 05060304051004 - APOTECA: 2022-03-24 Pharmacy compounding dosing device
• 05060304051011 - APOTECA: 2022-03-24 Pharmacy compounding dosing device
• 05060304050250 - APOTECAsyringe: 2021-03-09Automatic system for filling syringes
• 05060304050250 - APOTECAsyringe: 2021-03-09 Automatic system for filling syringes
• 05060304050823 - APOTECA: 2021-03-09 Transfer of liquid from a bag to syringes with APOTECAsyringe system