Amxor VacFlush Pre-Filled Normal Saline Flush Syringe

Basic Information

• Brand Name: Amxor VacFlush Pre-Filled Normal Saline Flush Syringe
• Primary DI: 00850049248068
• Version / Model: AVF-10
• Company Name: Amxor Healthcare LLC
• Labeler DUNS: 124112849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-07
• Public Version: 1
• Public Version Date: 2024-03-15
• Public Version Status: New
• Public Device Record Key: a72b1fe8-164e-456b-adb4-d6d5de09bb81

Device Description

AMXOR VASCFLUSH Pre-Filled Normal Saline Syringe is a pre-filled syringe with saline (0.9% sodium chloride injection, NaCl) and are used to help prevent vascular access systems from becoming blocked and to help remove any medication that may be left at the catheter site.

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
NGT	Saline, Vascular Access Flush	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35390	Irrigation syringe	A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850049248065	GS1	Box	40	In Commercial Distribution
Primary	00850049248068	GS1
Package	20850049248062	GS1	Case	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K220060	000

Device Sizes

Type	Value	Unit	Text
Total Volume	10	Milliliter