AMSafe® NeuFlo Needleless Connector AY0206

GUDID 30704411014755

AMSINO INTERNATIONAL, INC.

Basic intravenous administration set, noninvasive

• Primary Device ID: 30704411014755
• NIH Device Record Key: 5325a667-7471-4d0c-80a5-058004998058
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe® NeuFlo Needleless Connector
• Version Model Number: 1
• Catalog Number: AY0206
• 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	10704411014751 [Primary]
GS1	30704411014755 [Package]; Contains: 10704411014751; Package: Box [100 Units]; In Commercial Distribution
GS1	40704411014752 [Package]; Package: Case [600 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220267

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2025-07-01
• Device Publish Date: 2025-06-23

Devices Manufactured by AMSINO INTERNATIONAL, INC.

• 40704411021088 - AMSafe® I.V. Administration Set: 2026-01-06 108" (274 cm) Long Approximately 10 Drops/mL Y Injection Site Rotating Male Luer Lock Adapter
• 40704411020241 - AMSure® 0.9% Sodium Chloride lrrigation USP 100 mL, Sterile: 2025-12-15
• 40704411020258 - AMSure® Sterile Water for lrrigation USP 100 mL: 2025-12-15
• 00704411020267 - AMSure® Sterile Water for lrrigation USP 250 mL: 2025-12-15
• 40704411020272 - AMSure® 0.9% Sodium Chloride lrrigation USP 250 mL, Sterile: 2025-12-15
• 40704411020500 - AMSure® 0.9% Sodium Chloride lrrigation USP 500 mL, Sterile: 2025-12-15
• 40704411020517 - AMSure® Sterile Water for lrrigation USP 500 mL: 2025-12-15
• 40704411020524 - AMSure® 0.9% Sodium Chloride lrrigation USP 1000 mL, Sterile: 2025-12-15