Praxiject™ 0.9% NaCl 37053US

GUDID 30682686004506

3 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe

Medxl Inc

Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial

• Primary Device ID: 30682686004506
• NIH Device Record Key: 6f4e9761-7111-4c6a-874f-a1b8bd8f027c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Praxiject™ 0.9% NaCl
• Version Model Number: 37053US
• Catalog Number: 37053US
• Company DUNS: 259901445
• Company Name: Medxl Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com
• Phone: +1.514.695.7474
• Email: na@medxl.com

Device Dimensions

• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter
• Device Size Text, specify: 0
• Total Volume: 3 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10682686004502 [Primary]
GS1	20682686004509 [Package]; Contains: 10682686004502; Package: Case [100 Units]; In Commercial Distribution
GS1	30682686004506 [Package]; Contains: 20682686004509; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171109

FDA Product Code

• NGT: Saline, Vascular Access Flush

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-07-09
• Device Publish Date: 2018-03-19

On-Brand Devices [Praxiject™ 0.9% NaCl]

• 30682686004513: 5 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
• 30682686004506: 3 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
• 30682686004490: 10 mL of 0.9% Sodium Chloride Injection USP in a 10 mL syringe
• 30682686004483: 3 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe
• 10682686004472: 5 mL of 0.9% Sodium Chloride Injection USP in a 5 mL syringe