AMSafe ® Pre-Filled Normal Saline Flush Syringe

Basic Information

• Brand Name: AMSafe ® Pre-Filled Normal Saline Flush Syringe
• Primary DI: 30704411013482
• Version / Model: 1
• Catalog Number: IVF1005
• Company Name: AMSINO INTERNATIONAL, INC.
• Labeler DUNS: 825673239
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-05
• Public Version: 1
• Public Version Date: 2022-10-13
• Public Version Status: New
• Public Device Record Key: cbae249b-c66e-4c4a-9829-b6ce49418843
• Distribution End Date: 2022-10-05

Device Description

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

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NGT	Saline, Vascular Access Flush	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64786	Vascular catheter/cannula flush solution, non-anticoagulant, non-antimicrobial	A solution (e.g., saline, sterile water) intended to flush the lumen of an in situ intravenous access device (IVAD), typically a peripheral intravenous cannula or central venous catheter, to maintain patency; it does not include an anticoagulant or antimicrobial agent. Also known as lock solution, the device is available in a small container (e.g., bottle) or prefilled syringe. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	40704411013489	GS1	case	180	Not in Commercial Distribution	2022-10-05
Primary	30704411013482	GS1

Premarket Submissions

Submission Number	Supplement Number
K183473	000