Aquastat SFR

Basic Information

• Brand Name: Aquastat SFR
• Primary DI: 10859809005047
• Version / Model: 2S0708
• Catalog Number: 2S0708
• Company Name: MRP, LLC
• Labeler DUNS: 604012703
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 80
• Record Status: Published
• Publish Date: 2022-12-12
• Public Version: 1
• Public Version Date: 2022-12-20
• Public Version Status: New
• Public Device Record Key: 18a5c631-c6b7-450d-8aea-b4c26f022f3c

Device Description

Pre-filled Flush syringe with 0.9% NaCL (saline), 20mL, Sterile Field Ready

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: Yes
• 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
Primary	10859809005047	GS1
Unit of Use	00859809005040	GS1
Package	20859809005044	GS1	Case	4	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20 Milliliter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius