APOTECA

GUDID 05060304050038

Pharmacy compounding dosing device

AEA SRL

Hazardous fluid syringe

• Primary Device ID: 05060304050038
• NIH Device Record Key: 5e942383-8825-4f88-843a-533655316abb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APOTECA
• Version Model Number: ASN-20
• Company DUNS: 429415227
• Company Name: AEA SRL
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	05060304050038 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132011

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-13

On-Brand Devices [APOTECA]

• 05060304050243: Automatic system for compouding of non-hazardous drugs for pedriatic patients
• 05060304050199: APOTECAunit
• 05060304050182: APOTECAchemo
• 05060304050137: I.V. Transfer Set
• 05060304050120: I.V. Transfer Set
• 05060304050113: I.V. Transfer Set
• 05060304050106: I.V. Transfer Set
• 05060304050045: Pharmacy compounding dosing device
• 05060304050038: Pharmacy compounding dosing device
• 05060304050021: Pharmacy compounding dosing device
• 05060304050014: Pharmacy compounding dosing device
• 05060304050007: Pharmacy compounding dosing device
• 05060304050823: Transfer of liquid from a bag to syringes with APOTECAsyringe system
• 05060304051011: Pharmacy compounding dosing device
• 05060304051004: Pharmacy compounding dosing device
• 05060304050991: Pharmacy compounding dosing device
• 05060304050984: Pharmacy compounding dosing device
• 05060304050977: Pharmacy compounding dosing device
• 05060304050960: Pharmacy compounding dosing device