GBUK

Basic Information

• Brand Name: GBUK
• Primary DI: 06971564461139
• Version / Model: 10mL
• Catalog Number: PFS-10SSU
• Company Name: Jiangsu Caina Medical Co.,Ltd
• Labeler DUNS: 544543513
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-14
• Public Version: 1
• Public Version Date: 2025-05-22
• Public Version Status: New
• Public Device Record Key: 9583cb46-26cf-4b39-92ea-28dcf15e9766

Device Description

10 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl)

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: No
• 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: Yes
• 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
Package	16971564461136	GS1		30	In Commercial Distribution
Primary	06971564461139	GS1
Package	26971564461133	GS1		480	In Commercial Distribution
Package	36971564461130	GS1		1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K220060	000