AQUILAVIE

Basic Information

• Brand Name: AQUILAVIE
• Primary DI: 10810118890311
• Version / Model: J10341
• Catalog Number: J10341
• Company Name: Ahc Americas LLC
• Labeler DUNS: 118840015
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-04-20
• Public Version: 1
• Public Version Date: 2023-04-28
• Public Version Status: New
• Public Device Record Key: 543fed26-07e2-434e-b947-f2a928503fb4

Device Description

Disposable Insulin Syringe, U-100, 0.5mL 30G 5/16"/0.5CC (0.31mm x 8mm), 10pcs/bag, 10bags/box, 5boxes/case, 6cases/carton

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: No
• 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
34973	Insulin syringe/needle, safety	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; it includes an attached needle with a safety mechanism, such as cylinder/flap shielding or retraction into the barrel or sleeve after use, providing protection against needle sticks and rendering the device unusable. The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally precoated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients.. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20810118890318	GS1	Box	10	Not in Commercial Distribution	2023-04-20
Primary	10810118890311	GS1
Package	30810118890315	GS1	Case	5	Not in Commercial Distribution	2023-04-20
Package	40810118890312	GS1	Carton	6	Not in Commercial Distribution	2023-04-20
Unit of Use	00810118890314	GS1