Praxiject™ 0.9% NaCl

Basic Information

• Brand Name: Praxiject™ 0.9% NaCl
• Primary DI: 10682686004502
• Version / Model: 37053US
• Catalog Number: 37053US
• Company Name: Medxl Inc
• Labeler DUNS: 259901445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-19
• Public Version: 3
• Public Version Date: 2020-07-09
• Public Version Status: Update
• Public Device Record Key: 6f4e9761-7111-4c6a-874f-a1b8bd8f027c

Device Description

3 mL of 0.9% Sodium Chloride Injection USP in a 10 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
Package	30682686004506	GS1	Carton	6	In Commercial Distribution
Package	20682686004509	GS1	Case	100	In Commercial Distribution
Primary	10682686004502	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171109	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			3 mL fill in 10 mL syringe
Total Volume	3	Milliliter

Storage Conditions

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