ITL Biomedical ITL10004

GUDID 16971564464571

Prefilled Syringe with Saline 0.9%Sodium Chloride(0.9%NaCl),USP Fully Sterile

Jiangsu Caina Medical Co.,Ltd

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

• Primary Device ID: 16971564464571
• NIH Device Record Key: 41ad350c-7bb7-4965-8975-a94bd6c32b64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ITL Biomedical
• Version Model Number: 5mL
• Catalog Number: ITL10004
• Company DUNS: 544543513
• Company Name: Jiangsu Caina Medical Co.,Ltd
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971564464574 [Primary]
GS1	16971564464571 [Package]; Contains: 06971564464574; Package: [30 Units]; In Commercial Distribution
GS1	26971564464578 [Package]; Contains: 06971564464574; Package: [240 Units]; In Commercial Distribution

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: 2025-05-22
• Device Publish Date: 2025-05-14

On-Brand Devices [ITL Biomedical]

• 16971564464571: Prefilled Syringe with Saline 0.9%Sodium Chloride(0.9%NaCl),USP Fully Sterile
• 16971564464564: Prefilled Syringe with Saline 0.9%Sodium Chloride(0.9%NaCl),USP Fully Sterile