AMSafe ® Pre-Filled Normal Saline Flush Syringe IVF1005

GUDID 40704411013489

Pre-Filled Normal Saline Flush Syringe, 5 ml 0.9% Sodium Chloride Injection, USP, dust cover package, Sterile Fluid Path, Gamma radiation sterilization

AMSINO INTERNATIONAL, INC.

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

• Primary Device ID: 40704411013489
• NIH Device Record Key: cbae249b-c66e-4c4a-9829-b6ce49418843
• Commercial Distribution Discontinuation: 2022-10-05
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: AMSafe ® Pre-Filled Normal Saline Flush Syringe
• Version Model Number: 1
• Catalog Number: IVF1005
• 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	30704411013482 [Primary]
GS1	40704411013489 [Package]; Contains: 30704411013482; Package: case [180 Units]; Discontinued: 2022-10-05; Not 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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-13
• Device Publish Date: 2022-10-05

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

• 40704411014844: Pre-Filled Normal Saline Flush Syringe, 10 mL 0.9% Sodium Chloride Injection, USP
• 40704411013526: Pre-Filled Normal Saline Flush Syringe, 10 ml 0.9% Sodium Chloride Injection, USP, poly blister
• 30704411013512: Pre-Filled Normal Saline Flush Syringe, 5 ml 0.9% Sodium Chloride Injection, USP, poly blister
• 40704411013502: Pre-Filled Normal Saline Flush Syringe, 3 ml 0.9% Sodium Chloride Injection, USP, poly blister
• 30704411013499: Pre-Filled Normal Saline Flush Syringe, 10 ml 0.9% Sodium Chloride Injection, USP, dust cover pa
• 40704411013489: Pre-Filled Normal Saline Flush Syringe, 5 ml 0.9% Sodium Chloride Injection, USP, dust cover pac
• 40704411013472: Pre-Filled Normal Saline Flush Syringe, 3 ml 0.9% Sodium Chloride Injection, USP, dust cover pac
• 30704411015141: AMSafe ® Pre-Filled Normal Saline Flush Syringe , 10 mL 0.9% Sodium Chloride Injection, USP
• 40704411016640: AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 10mL, use only in flushin
• 40704411016633: AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 5mL, use only in flushing
• 40704411016626: AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 3mL, use only in flushing
• 40704411016619: AMSafe ® Pre-Filled Normal Saline Flush Syringe, 10mL, use only in flushing compatible intraven
• 40704411016602: AMSafe ® Pre-Filled Normal Saline Flush Syringe, 5mL, use only in flushing compatible intraveno
• 40704411016596: AMSafe ® Pre-Filled Normal Saline Flush Syringe, 3mL, use only in flushing compatible intraveno