Pre-Filled Saline Flush Syringes,Sterile,10mL

GUDID 08401173345264

DYNAREX CORPORATION

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

• Primary Device ID: 08401173345264
• NIH Device Record Key: 03a5b143-f1a7-491b-8854-b858c4a9a52b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pre-Filled Saline Flush Syringes,Sterile,10mL
• Version Model Number: 7059
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 30
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840117334519 [Package]; Contains: 00840117334526; Package: Case [16 Units]; In Commercial Distribution
GS1	00840117334526 [Primary]
GS1	08401173345264 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220060

FDA Product Code

• NGT: Saline, Vascular Access Flush

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-15
• Device Publish Date: 2024-03-07

On-Brand Devices [Pre-Filled Saline Flush Syringes,Sterile,10mL]

• 08401173345264: 7059
• 00840117334533: 7059