GBUK PFS-5SSU

GUDID 16971564461129

5ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP

Jiangsu Caina Medical Co.,Ltd

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

• Primary Device ID: 16971564461129
• NIH Device Record Key: 6866294b-1697-44ec-a2fd-e72778976880
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GBUK
• Version Model Number: 5mL
• Catalog Number: PFS-5SSU
• Company DUNS: 544543513
• Company Name: Jiangsu Caina Medical Co.,Ltd
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971564461122 [Primary]
GS1	16971564461129 [Package]; Contains: 06971564461122; Package: [30 Units]; In Commercial Distribution
GS1	26971564461126 [Package]; Contains: 06971564461122; Package: [720 Units]; In Commercial Distribution
GS1	36971564461123 [Package]; Contains: 06971564461122; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220060

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: 2025-05-22
• Device Publish Date: 2025-05-14

On-Brand Devices [GBUK]

• 06971564462976: 10ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9%NaCl),USP
• 16971564461136: 10 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl)
• 16971564461129: 5ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP
• 06971564461115: 3 ml SP Prefilled saline syringe 0.9%Sodium Chloride(0.9%Na Cl),USP
• 06971564461108: 10 ml XS Prefilled saline syringe 0.9%Sodium Chloride(0.9% Na Cl), USP