AutoDrop

Basic Information

• Brand Name: AutoDrop
• Primary DI: 00384706050010
• Version / Model: OP 6050
• Company Name: OWEN MUMFORD USA INCORPORATED
• Labeler DUNS: 803401454
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-20
• Public Version: 1
• Public Version Date: 2023-06-28
• Public Version Status: New
• Public Device Record Key: d974df6f-82ca-400a-bbd7-dee9cb4f78a9

Device Description

Autodrop device in a bag

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KCM	Dropper, Ent	Ear, Nose, Throat	874.5220	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61580	Eye dropper bottle aid	A non-sterile device intended to be attached to an eye dropper bottle to assist with the self-administration of an eye irrigation/treatment solution. It is typically a plastic device intended to assist with positioning of the nozzle, focusing of the eye, and/or squeezing of the bottle. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00384706050010	GS1