10ml Oral Syringe Amber

Basic Information

• Brand Name: 10ml Oral Syringe Amber
• Primary DI: 00818392011807
• Version / Model: 20010OA
• Company Name: Sol-Millennium Medical, Inc.
• Labeler DUNS: 069590113
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-03-18
• Public Version: 3
• Public Version Date: 2025-12-25
• Public Version Status: Update
• Public Device Record Key: 50bdeb8a-7978-495d-bc34-603da8d7deed

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65823	Non-ISO80369-3-standardized oral syringe, single-use	A manual device consisting of a calibrated hollow barrel (cylinder) and a moveable plunger intended for the administration of oral medication. The tip is not formatted according to the standard for small-bore connectors for enteral applications (ISO 80369-3) [i.e., not ENFit], however the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10818392011804	GS1	Box	100	In Commercial Distribution
Primary	00818392011807	GS1
Package	20818392011801	GS1	Case	400	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]