Praxiject™ 0.9% NaCl

Basic Information

• Brand Name: Praxiject™ 0.9% NaCl
• Primary DI: 10682686004762
• Version / Model: 3706US
• Catalog Number: 3706US
• Company Name: Medxl Inc
• Labeler DUNS: 259901445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-19
• Public Version: 1
• Public Version Date: 2024-06-27
• Public Version Status: New
• Public Device Record Key: 9c6852e0-18a7-4ee8-9ad2-15b58d698cc2

Device Description

20 mL of 0.9% Sodium Chloride Injection USP in a 20 mL syringe

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: 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
NGT	Saline, Vascular Access Flush	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64786	Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial	A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10682686004762	GS1
Package	20682686004769	GS1	Case	60	In Commercial Distribution
Package	30682686004766	GS1	Carton	6	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K231754	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 mL fill in 20 mL syringe
Total Volume	20	Milliliter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius