APOTECA

Basic Information

• Brand Name: APOTECA
• Primary DI: 05060304051004
• Version / Model: ASN-20-K-NCE
• Company Name: AEA SRL
• Labeler DUNS: 429415227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-16
• Public Version: 1
• Public Version Date: 2022-03-24
• Public Version Status: New
• Public Device Record Key: 343b016b-b1e8-4fb1-8a95-89c2d56064c6

Device Description

Pharmacy compounding dosing device

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32130	Hazardous fluid syringe	A sterile device designed to promote the safe (leak-free) handling of fluids and medications that are potentially hazardous or cytotoxic, such as those used for chemotherapy, radioactive isotopes, or blood products. It consists of a calibrated hollow barrel (cylinder) connected to a needle-free port (valve), and a moveable plunger used to aspirate and expel the fluid into and out of the cylinder. It is typically made of plastic and silicone materials and used for drug/fluid preparation, for their administration to the patient, and for waste handling of the expended device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060304051004	GS1

Premarket Submissions

Submission Number	Supplement Number
K132011	000