AMSafe® Pre-Filled Normal Saline Flush Syringe IVF2020

GUDID 30704411009966

AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field 20 mL Fill • Preservative Free

AMSINO INTERNATIONAL, INC.

Vascular catheter flush syringe 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 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: 30704411009966
• NIH Device Record Key: 40e7bbc9-af09-4a1b-9653-8ffed9c498b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe® Pre-Filled Normal Saline Flush Syringe
• Version Model Number: 1
• Catalog Number: IVF2020
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00704411009965 [Primary]
GS1	30704411009966 [Package]; Contains: 00704411009965; Package: Box [30 Units]; In Commercial Distribution
GS1	40704411009963 [Package]; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183473

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: 2020-02-18
• Device Publish Date: 2020-02-10

On-Brand Devices [AMSafe® Pre-Filled Normal Saline Flush Syringe]

• 10704411010005: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel
• 10704411009993: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel
• 10704411009986: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel
• 10704411009979: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Fiel
• 30704411009966: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Flui
• 30704411009959: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Flui
• 00704411009941: AMSafe® Pre-Filled Normal Saline Flush Syringe 0.9% Sodium Chloride Injection, USP Sterile Flui
• 00704411009934: 0.9% Sodium Chloride Injection, USP Sterile Fluid & Path Do Not Place Syringe on a Sterile Field